Establishments and listings

TruSignal SpO2 PediTip Sensor (TS-SP-D), TruSignal SpO2 PediTip Sensor, GE connector (TS-SP3-GE)

GE HEALTHCARE FINLAND OY · HELSINKI Uusimaa, FI

Develop Specifications But Do Not Manufacture At This FacilityReg. 9610105DQA
K number
K103802
Proprietary name
TruSignal SpO2 PediTip Sensor (TS-SP-D), TruSignal SpO2 PediTip Sensor, GE connector (TS-SP3-GE)
Establishment type
Develop Specifications But Do Not Manufacture At This Facility
Registration
Registration number
9610105
FEI number
3002806783
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
GE HEALTHCARE FINLAND OY
Address line 1
KUORTANEENKATU 2
City
HELSINKI Uusimaa
Iso country code
FI
Postal code
FIN-00510
US agent
Name
Tracey Holevas
Business name
GE HealthCare Technologies, Inc
Bus phone area code
262
Bus phone num
3092157
Email address
tracey.holevas@gehealthcare.com
Address line 1
3000 N. Grandview BLVD
City
Waukesha
State code
WI
Iso country code
US
Zip code
53188
Owner operator
Firm name
GE HealthCare Technologies Inc.
Owner operator number
9912004
Contact address
Address 1
3000 N. Grandview Blvd
City
Waukesha
State code
WI
Iso country code
US
Postal code
53188
Products
  1. Product code
    DQA
    Created date
    2011-08-11
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Oximeter
    Medical specialty description
    Cardiovascular
    Regulation number
    870.2700
    Device class
    2
Establishments and listings

2025350-001 SpO2 Interconnect cable, Nellcor OxiMax, 3m/10ft, Corometrics only

GE HEALTHCARE FINLAND OY · HELSINKI Uusimaa, FI

Develop Specifications But Do Not Manufacture At This FacilityReg. 9610105HGM
K number
K050583
Proprietary name
2025350-001 SpO2 Interconnect cable, Nellcor OxiMax, 3m/10ft, Corometrics only
Establishment type
Develop Specifications But Do Not Manufacture At This Facility
Registration
Registration number
9610105
FEI number
3002806783
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
GE HEALTHCARE FINLAND OY
Address line 1
KUORTANEENKATU 2
City
HELSINKI Uusimaa
Iso country code
FI
Postal code
FIN-00510
US agent
Name
Tracey Holevas
Business name
GE HealthCare Technologies, Inc
Bus phone area code
262
Bus phone num
3092157
Email address
tracey.holevas@gehealthcare.com
Address line 1
3000 N. Grandview BLVD
City
Waukesha
State code
WI
Iso country code
US
Zip code
53188
Owner operator
Firm name
GE HealthCare Technologies Inc.
Owner operator number
9912004
Contact address
Address 1
3000 N. Grandview Blvd
City
Waukesha
State code
WI
Iso country code
US
Postal code
53188
Products
  1. Product code
    HGM
    Created date
    2010-08-04
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    System, Monitoring, Perinatal
    Medical specialty description
    Obstetrics/Gynecology
    Regulation number
    884.2740
    Device class
    2
    K number
    K050583
Establishments and listings

Pedi-lite+ sensor, disposable, Pediatric, 8001948, E-sCAiOE +24

GE HEALTHCARE FINLAND OY · HELSINKI Uusimaa, FI

Develop Specifications But Do Not Manufacture At This Facility +1Reg. 9610105CBRCCK
K number
K211171
Proprietary name
Pedi-lite+ sensor, disposable, Pediatric, 8001948, E-sCAiOE, E-sCAiOVX, SPIROMETRY TUBE, DISPOSABLE, 2M/7FT 890031, D-lite+ sensor, disposable, Adult, 896952, E-sCOVX, D-Lite+ Spirometry Kit 3m/10ft, 8004382, Gas Sampling Line, Disposable, PVC/PE, 2m/7ft, 2097307-001, D-lite++ Patient Spirometry Set, 2m/7ft, 2104297-001, E-sCAiO, SPIROMETRY TUBE, DISPOSABLE, 6M/20FT 891191-HEL, D-fend Pro+ Water Trap, M1200227, D-fend Pro Water Trap, M1182629, CARESCAPE Respiratory Modules, E-sCAiOV, E-sCOV, Pedi-lite+ Spirometry Kit 2m/7ft, 8002718, Gas Sampling Line, Disposable, PVC/PE, 3m/10ft, 2097307-002, SPIROMETRY TUBE, DISPOSABLE, 3M/10FT 884101, D-lite++ Patient Spirometry Set, 3m/10ft, 2104297-002, D-lite sensor, reusable, Adult, 733910-HEL, E-sCO, E-sCAiOVE, Pedi-Lite+ Spirometry Kit 3m/10ft, M1032634, Gas Sampling Line, Disposable, PVC/PE, 6m/20ft, 2097307-003, Pedi-lite sensor, reusable, Pediatric, 73393
Establishment type
Develop Specifications But Do Not Manufacture At This Facility, Manufacture Medical Device
Registration
Registration number
9610105
FEI number
3002806783
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
GE HEALTHCARE FINLAND OY
Address line 1
KUORTANEENKATU 2
City
HELSINKI Uusimaa
Iso country code
FI
Postal code
FIN-00510
US agent
Name
Tracey Holevas
Business name
GE HealthCare Technologies, Inc
Bus phone area code
262
Bus phone num
3092157
Email address
tracey.holevas@gehealthcare.com
Address line 1
3000 N. Grandview BLVD
City
Waukesha
State code
WI
Iso country code
US
Zip code
53188
Owner operator
Firm name
GE HealthCare Technologies Inc.
Owner operator number
9912004
Contact address
Address 1
3000 N. Grandview Blvd
City
Waukesha
State code
WI
Iso country code
US
Postal code
53188
Products
  1. Product code
    CBR
    Created date
    2021-11-15
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
    Medical specialty description
    Anesthesiology
    Regulation number
    868.1700
    Device class
    2
  2. Product code
    CCK
    Created date
    2021-11-15
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
    Medical specialty description
    Anesthesiology
    Regulation number
    868.1400
    Device class
    2
  3. Product code
    CBQ
    Created date
    2021-11-15
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
    Medical specialty description
    Anesthesiology
    Regulation number
    868.1500
    Device class
    2
  4. Product code
    NHP
    Created date
    2021-11-15
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
    Medical specialty description
    Anesthesiology
    Regulation number
    868.1500
    Device class
    2
  5. Product code
    BZL
    Created date
    2021-11-15
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Computer, Oxygen-Uptake
    Medical specialty description
    Anesthesiology
    Regulation number
    868.1730
    Device class
    2
  6. Product code
    CCL
    Created date
    2021-11-15
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Analyzer, Gas, Oxygen, Gaseous-Phase
    Medical specialty description
    Anesthesiology
    Regulation number
    868.1720
    Device class
    2
  7. Product code
    NHQ
    Created date
    2021-11-15
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
    Medical specialty description
    Anesthesiology
    Regulation number
    868.1500
    Device class
    2
  8. Product code
    CBS
    Created date
    2021-11-15
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
    Medical specialty description
    Anesthesiology
    Regulation number
    868.1620
    Device class
    2
  9. Product code
    BZK
    Created date
    2021-11-15
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Spirometer, Monitoring (W/Wo Alarm)
    Medical specialty description
    Anesthesiology
    Regulation number
    868.1850
    Device class
    2
  10. Product code
    NHO
    Created date
    2021-11-15
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
    Medical specialty description
    Anesthesiology
    Regulation number
    868.1500
    Device class
    2
  11. Product code
    CAP
    Created date
    2021-11-15
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
    Medical specialty description
    Anesthesiology
    Regulation number
    868.2600
    Device class
    2
Establishments and listings

CARESCAPE MONITOR B450, CARESCAPE MONITOR B450-LI +2

GE HEALTHCARE FINLAND OY · HELSINKI Uusimaa, FI

Manufacture Medical DeviceReg. 9610105CAPDQA
K number
K132533
Proprietary name
CARESCAPE MONITOR B450, CARESCAPE MONITOR B450-LI, CARESCAPE Monitor B450 BEDRAIL HOOK: BEDRAIL HOOK UNIT, CARESCAPE B450 BRH
Establishment type
Manufacture Medical Device
Registration
Registration number
9610105
FEI number
3002806783
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
GE HEALTHCARE FINLAND OY
Address line 1
KUORTANEENKATU 2
City
HELSINKI Uusimaa
Iso country code
FI
Postal code
FIN-00510
US agent
Name
Tracey Holevas
Business name
GE HealthCare Technologies, Inc
Bus phone area code
262
Bus phone num
3092157
Email address
tracey.holevas@gehealthcare.com
Address line 1
3000 N. Grandview BLVD
City
Waukesha
State code
WI
Iso country code
US
Zip code
53188
Owner operator
Firm name
GE HealthCare Technologies Inc.
Owner operator number
9912004
Contact address
Address 1
3000 N. Grandview Blvd
City
Waukesha
State code
WI
Iso country code
US
Postal code
53188
Products
  1. Product code
    CAP
    Created date
    2013-12-05
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
    Medical specialty description
    Anesthesiology
    Regulation number
    868.2600
    Device class
    2
  2. Product code
    DQA
    Created date
    2013-12-05
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Oximeter
    Medical specialty description
    Cardiovascular
    Regulation number
    870.2700
    Device class
    2
  3. Product code
    CBQ
    Created date
    2013-12-05
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
    Medical specialty description
    Anesthesiology
    Regulation number
    868.1500
    Device class
    2
  4. Product code
    DRT
    Created date
    2013-12-05
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
    Medical specialty description
    Cardiovascular
    Regulation number
    870.2300
    Device class
    2
  5. Product code
    BZK
    Created date
    2013-12-05
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Spirometer, Monitoring (W/Wo Alarm)
    Medical specialty description
    Anesthesiology
    Regulation number
    868.1850
    Device class
    2
  6. Product code
    DXG
    Created date
    2013-12-05
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Computer, Diagnostic, Pre-Programmed, Single-Function
    Medical specialty description
    Cardiovascular
    Regulation number
    870.1435
    Device class
    2
  7. Product code
    DSI
    Created date
    2013-12-05
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Detector And Alarm, Arrhythmia
    Medical specialty description
    Cardiovascular
    Regulation number
    870.1025
    Device class
    2
  8. Product code
    NHQ
    Created date
    2013-12-05
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
    Medical specialty description
    Anesthesiology
    Regulation number
    868.1500
    Device class
    2
  9. Product code
    BZL
    Created date
    2013-12-05
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Computer, Oxygen-Uptake
    Medical specialty description
    Anesthesiology
    Regulation number
    868.1730
    Device class
    2
  10. Product code
    KRB
    Created date
    2013-12-05
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Probe, Thermodilution
    Medical specialty description
    Cardiovascular
    Regulation number
    870.1915
    Device class
    2
  11. Product code
    DPZ
    Created date
    2013-12-05
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Oximeter, Ear
    Medical specialty description
    Cardiovascular
    Regulation number
    870.2710
    Device class
    2
  12. Product code
    OLW
    Created date
    2013-12-05
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Index-Generating Electroencephalograph Software
    Medical specialty description
    Neurology
    Regulation number
    882.1400
    Device class
    2
  13. +21 more not shown
Establishments and listings

CARESCAPE MONITOR B850, F7 Frame +4

GE HEALTHCARE FINLAND OY · HELSINKI Uusimaa, FI

Manufacture Medical DeviceReg. 9610105CCKOLT
K number
K131414
Proprietary name
CARESCAPE MONITOR B850, F7 Frame, F5 Frame, USB Remote Control, CARESCAPE D19KT, CARESCAPE MONITOR B850-LI
Establishment type
Manufacture Medical Device
Registration
Registration number
9610105
FEI number
3002806783
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
GE HEALTHCARE FINLAND OY
Address line 1
KUORTANEENKATU 2
City
HELSINKI Uusimaa
Iso country code
FI
Postal code
FIN-00510
US agent
Name
Tracey Holevas
Business name
GE HealthCare Technologies, Inc
Bus phone area code
262
Bus phone num
3092157
Email address
tracey.holevas@gehealthcare.com
Address line 1
3000 N. Grandview BLVD
City
Waukesha
State code
WI
Iso country code
US
Zip code
53188
Owner operator
Firm name
GE HealthCare Technologies Inc.
Owner operator number
9912004
Contact address
Address 1
3000 N. Grandview Blvd
City
Waukesha
State code
WI
Iso country code
US
Postal code
53188
Products
  1. Product code
    CCK
    Created date
    2013-09-17
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
    Medical specialty description
    Anesthesiology
    Regulation number
    868.1400
    Device class
    2
  2. Product code
    OLT
    Created date
    2013-09-17
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Non-Normalizing Quantitative Electroencephalograph Software
    Medical specialty description
    Neurology
    Regulation number
    882.1400
    Device class
    2
  3. Product code
    CCL
    Created date
    2013-09-17
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Analyzer, Gas, Oxygen, Gaseous-Phase
    Medical specialty description
    Anesthesiology
    Regulation number
    868.1720
    Device class
    2
  4. Product code
    DPZ
    Created date
    2013-09-17
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Oximeter, Ear
    Medical specialty description
    Cardiovascular
    Regulation number
    870.2710
    Device class
    2
  5. Product code
    BZL
    Created date
    2013-09-17
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Computer, Oxygen-Uptake
    Medical specialty description
    Anesthesiology
    Regulation number
    868.1730
    Device class
    2
  6. Product code
    GWQ
    Created date
    2013-09-17
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Full-Montage Standard Electroencephalograph
    Medical specialty description
    Neurology
    Regulation number
    882.1400
    Device class
    2
  7. Product code
    DPS
    Created date
    2013-09-17
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Electrocardiograph
    Medical specialty description
    Cardiovascular
    Regulation number
    870.2340
    Device class
    2
  8. Product code
    NHO
    Created date
    2013-09-17
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
    Medical specialty description
    Anesthesiology
    Regulation number
    868.1500
    Device class
    2
  9. Product code
    DQA
    Created date
    2013-09-17
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Oximeter
    Medical specialty description
    Cardiovascular
    Regulation number
    870.2700
    Device class
    2
  10. Product code
    DXN
    Created date
    2013-09-17
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    System, Measurement, Blood-Pressure, Non-Invasive
    Medical specialty description
    Cardiovascular
    Regulation number
    870.1130
    Device class
    2
  11. Product code
    CBS
    Created date
    2013-09-17
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
    Medical specialty description
    Anesthesiology
    Regulation number
    868.1620
    Device class
    2
  12. Product code
    DRT
    Created date
    2013-09-17
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
    Medical specialty description
    Cardiovascular
    Regulation number
    870.2300
    Device class
    2
  13. +21 more not shown
Establishments and listings

Single-width airway module E-miniC, Mini D-fend Water trap

GE HEALTHCARE FINLAND OY · HELSINKI Uusimaa, FI

Develop Specifications But Do Not Manufacture At This Facility +1Reg. 9610105CCK
K number
K052582
Proprietary name
Single-width airway module E-miniC, Mini D-fend Water trap
Establishment type
Develop Specifications But Do Not Manufacture At This Facility, Manufacture Medical Device
Registration
Registration number
9610105
FEI number
3002806783
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
GE HEALTHCARE FINLAND OY
Address line 1
KUORTANEENKATU 2
City
HELSINKI Uusimaa
Iso country code
FI
Postal code
FIN-00510
US agent
Name
Tracey Holevas
Business name
GE HealthCare Technologies, Inc
Bus phone area code
262
Bus phone num
3092157
Email address
tracey.holevas@gehealthcare.com
Address line 1
3000 N. Grandview BLVD
City
Waukesha
State code
WI
Iso country code
US
Zip code
53188
Owner operator
Firm name
GE HealthCare Technologies Inc.
Owner operator number
9912004
Contact address
Address 1
3000 N. Grandview Blvd
City
Waukesha
State code
WI
Iso country code
US
Postal code
53188
Products
  1. Product code
    CCK
    Created date
    2010-08-24
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
    Medical specialty description
    Anesthesiology
    Regulation number
    868.1400
    Device class
    2
Establishments and listings

2021406-001 SpO2 Interconnect cable, 2021406-002 SpO2 Interconnect cable +2

GE HEALTHCARE FINLAND OY · HELSINKI Uusimaa, FI

Develop Specifications But Do Not Manufacture At This FacilityReg. 9610105MHX
K number
K051367
Proprietary name
2021406-001 SpO2 Interconnect cable, 2021406-002 SpO2 Interconnect cable, Nellcor OxiMax, 3m/10ft, Nellcor OxiMax, 1.2m/3.9ft
Establishment type
Develop Specifications But Do Not Manufacture At This Facility
Registration
Registration number
9610105
FEI number
3002806783
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
GE HEALTHCARE FINLAND OY
Address line 1
KUORTANEENKATU 2
City
HELSINKI Uusimaa
Iso country code
FI
Postal code
FIN-00510
US agent
Name
Tracey Holevas
Business name
GE HealthCare Technologies, Inc
Bus phone area code
262
Bus phone num
3092157
Email address
tracey.holevas@gehealthcare.com
Address line 1
3000 N. Grandview BLVD
City
Waukesha
State code
WI
Iso country code
US
Zip code
53188
Owner operator
Firm name
GE HealthCare Technologies Inc.
Owner operator number
9912004
Contact address
Address 1
3000 N. Grandview Blvd
City
Waukesha
State code
WI
Iso country code
US
Postal code
53188
Products
  1. Product code
    MHX
    Created date
    2010-07-28
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
    Medical specialty description
    Cardiovascular
    Regulation number
    870.1025
    Device class
    2
Establishments and listings

CARESCAPE MONITOR B650, CARESCAPE Monitor B650-LI

GE HEALTHCARE FINLAND OY · HELSINKI Uusimaa, FI

Manufacture Medical DeviceReg. 9610105DPSDRT
K number
K131223
Proprietary name
CARESCAPE MONITOR B650, CARESCAPE Monitor B650-LI
Establishment type
Manufacture Medical Device
Registration
Registration number
9610105
FEI number
3002806783
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
GE HEALTHCARE FINLAND OY
Address line 1
KUORTANEENKATU 2
City
HELSINKI Uusimaa
Iso country code
FI
Postal code
FIN-00510
US agent
Name
Tracey Holevas
Business name
GE HealthCare Technologies, Inc
Bus phone area code
262
Bus phone num
3092157
Email address
tracey.holevas@gehealthcare.com
Address line 1
3000 N. Grandview BLVD
City
Waukesha
State code
WI
Iso country code
US
Zip code
53188
Owner operator
Firm name
GE HealthCare Technologies Inc.
Owner operator number
9912004
Contact address
Address 1
3000 N. Grandview Blvd
City
Waukesha
State code
WI
Iso country code
US
Postal code
53188
Products
  1. Product code
    DPS
    Created date
    2013-09-04
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Electrocardiograph
    Medical specialty description
    Cardiovascular
    Regulation number
    870.2340
    Device class
    2
  2. Product code
    DRT
    Created date
    2013-09-04
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
    Medical specialty description
    Cardiovascular
    Regulation number
    870.2300
    Device class
    2
  3. Product code
    OLW
    Created date
    2013-09-04
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Index-Generating Electroencephalograph Software
    Medical specialty description
    Neurology
    Regulation number
    882.1400
    Device class
    2
  4. Product code
    CBQ
    Created date
    2013-09-04
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
    Medical specialty description
    Anesthesiology
    Regulation number
    868.1500
    Device class
    2
  5. Product code
    DXN
    Created date
    2013-09-04
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    System, Measurement, Blood-Pressure, Non-Invasive
    Medical specialty description
    Cardiovascular
    Regulation number
    870.1130
    Device class
    2
  6. Product code
    DQA
    Created date
    2013-09-04
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Oximeter
    Medical specialty description
    Cardiovascular
    Regulation number
    870.2700
    Device class
    2
  7. Product code
    DSJ
    Created date
    2013-09-04
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Alarm, Blood-Pressure
    Medical specialty description
    Cardiovascular
    Regulation number
    870.1100
    Device class
    2
  8. Product code
    BZK
    Created date
    2013-09-04
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Spirometer, Monitoring (W/Wo Alarm)
    Medical specialty description
    Anesthesiology
    Regulation number
    868.1850
    Device class
    2
  9. Product code
    DSI
    Created date
    2013-09-04
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Detector And Alarm, Arrhythmia
    Medical specialty description
    Cardiovascular
    Regulation number
    870.1025
    Device class
    2
  10. Product code
    CAP
    Created date
    2013-09-04
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
    Medical specialty description
    Anesthesiology
    Regulation number
    868.2600
    Device class
    2
  11. Product code
    OMC
    Created date
    2013-09-04
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Reduced- Montage Standard Electroencephalograph
    Medical specialty description
    Neurology
    Regulation number
    882.1400
    Device class
    2
  12. Product code
    CCK
    Created date
    2013-09-04
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
    Medical specialty description
    Anesthesiology
    Regulation number
    868.1400
    Device class
    2
  13. +21 more not shown
Establishments and listings

CARESCAPE B850, E-musb +5

GE HEALTHCARE FINLAND OY · HELSINKI Uusimaa, FI

Manufacture Medical DeviceReg. 9610105DXNDSJ
K number
K213336
Proprietary name
CARESCAPE B850, E-musb, CARESCAPE D19KT VER01, CARESCAPE RAD, USB Remote Control, F7-01 Frame, F5-01 Frame
Establishment type
Manufacture Medical Device
Registration
Registration number
9610105
FEI number
3002806783
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
GE HEALTHCARE FINLAND OY
Address line 1
KUORTANEENKATU 2
City
HELSINKI Uusimaa
Iso country code
FI
Postal code
FIN-00510
US agent
Name
Tracey Holevas
Business name
GE HealthCare Technologies, Inc
Bus phone area code
262
Bus phone num
3092157
Email address
tracey.holevas@gehealthcare.com
Address line 1
3000 N. Grandview BLVD
City
Waukesha
State code
WI
Iso country code
US
Zip code
53188
Owner operator
Firm name
GE HealthCare Technologies Inc.
Owner operator number
9912004
Contact address
Address 1
3000 N. Grandview Blvd
City
Waukesha
State code
WI
Iso country code
US
Postal code
53188
Products
  1. Product code
    DXN
    Created date
    2022-04-20
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    System, Measurement, Blood-Pressure, Non-Invasive
    Medical specialty description
    Cardiovascular
    Regulation number
    870.1130
    Device class
    2
  2. Product code
    DSJ
    Created date
    2022-04-20
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Alarm, Blood-Pressure
    Medical specialty description
    Cardiovascular
    Regulation number
    870.1100
    Device class
    2
  3. Product code
    FLL
    Created date
    2022-04-20
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Continuous Measurement Thermometer
    Medical specialty description
    General Hospital
    Regulation number
    880.2910
    Device class
    2
  4. Product code
    MLD
    Created date
    2022-04-20
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Monitor, St Segment With Alarm
    Medical specialty description
    Cardiovascular
    Regulation number
    870.1025
    Device class
    2
  5. Product code
    NHP
    Created date
    2022-04-20
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
    Medical specialty description
    Anesthesiology
    Regulation number
    868.1500
    Device class
    2
  6. Product code
    DSI
    Created date
    2022-04-20
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Detector And Alarm, Arrhythmia
    Medical specialty description
    Cardiovascular
    Regulation number
    870.1025
    Device class
    2
  7. Product code
    BZQ
    Created date
    2022-04-20
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Monitor, Breathing Frequency
    Medical specialty description
    Anesthesiology
    Regulation number
    868.2375
    Device class
    2
  8. Product code
    MHX
    Created date
    2022-04-20
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
    Medical specialty description
    Cardiovascular
    Regulation number
    870.1025
    Device class
    2
  9. Product code
    DPS
    Created date
    2022-04-20
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Electrocardiograph
    Medical specialty description
    Cardiovascular
    Regulation number
    870.2340
    Device class
    2
  10. Product code
    DQA
    Created date
    2022-04-20
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Oximeter
    Medical specialty description
    Cardiovascular
    Regulation number
    870.2700
    Device class
    2
  11. Product code
    BZL
    Created date
    2022-04-20
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Computer, Oxygen-Uptake
    Medical specialty description
    Anesthesiology
    Regulation number
    868.1730
    Device class
    2
  12. Product code
    DRT
    Created date
    2022-04-20
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
    Medical specialty description
    Cardiovascular
    Regulation number
    870.2300
    Device class
    2
  13. +23 more not shown
Establishments and listings

QUICK CAL Calibration Gas (755587), Calibration Gas +2

GE HEALTHCARE FINLAND OY · HELSINKI Uusimaa, FI

Develop Specifications But Do Not Manufacture At This FacilityReg. 9610105BXK
Proprietary name
QUICK CAL Calibration Gas (755587), Calibration Gas, Calibration Gas (755571-HEL), QUICK CAL Calibration Gas
Establishment type
Develop Specifications But Do Not Manufacture At This Facility
Registration
Registration number
9610105
FEI number
3002806783
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
GE HEALTHCARE FINLAND OY
Address line 1
KUORTANEENKATU 2
City
HELSINKI Uusimaa
Iso country code
FI
Postal code
FIN-00510
US agent
Name
Tracey Holevas
Business name
GE HealthCare Technologies, Inc
Bus phone area code
262
Bus phone num
3092157
Email address
tracey.holevas@gehealthcare.com
Address line 1
3000 N. Grandview BLVD
City
Waukesha
State code
WI
Iso country code
US
Zip code
53188
Owner operator
Firm name
GE HealthCare Technologies Inc.
Owner operator number
9912004
Contact address
Address 1
3000 N. Grandview Blvd
City
Waukesha
State code
WI
Iso country code
US
Postal code
53188
Products
  1. Product code
    BXK
    Created date
    2011-04-18
    Owner operator number
    9912004
    Harmonized identifiers (openFDA)
    Device name
    Gas, Calibration (Specified Concentration)
    Medical specialty description
    Anesthesiology
    Regulation number
    868.6400
    Device class
    1

50 records share this identifier (an establishment lists each device separately); the first 10 are shown.

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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.