510(k) clearances

Sempulse Halo Vital Signs Monitor

Sempulse Corporation · Cardiovascular

K232495Substantially EquivalentTraditionalDQA
Open FDA's page for this record
Third party flag
N
City
San Marcos
Advisory committee description
Cardiovascular
Address 1
3055 Hunter Rd.
Address 2
Suite 175a
Statement or summary
Statement
Product code
DQA
Zip code
78666
Applicant
Sempulse Corporation
Decision date
2024-05-16
Decision code
SESE
Country code
US
Device name
Sempulse Halo Vital Signs Monitor
Advisory committee
CV
Contact
Matt Barrera
K number
K232495
State
TX
Date received
2023-08-17
Review advisory committee
AN
Postal code
78666
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Oximeter
Medical specialty description
Cardiovascular
Regulation number
870.2700
Device class
2
Registration number
3044675072, 3010526986, 3017953522, 3003965134, 3008729547, 3006713849, 3003589956, 2029015, 3012302888, 1314417, 3010390468, 3016674095, 3014541700, 3009156722, 3024512705, 3007699081, 3016170326, 3003622639, 3043513123, 9614500, 3013896610, 3014856521, 3013679558, 3032948391, 3007307487, 2434008, 3014848734, 3004091281, 9610816, 3032391, 2025816, 9617566, 3003971136, 2022648, 3008483389, 3038761440, 8020893, 8021084, 3007603826, 3012933969 +357 more
FEI number
3044675072, 3010526986, 3017953522, 3003965134, 3008729547, 3006713849, 3003589956, 3012302888, 1000292048, 1314417, 3010390468, 3016674095, 3014541700, 3009156722, 3024512705, 3007699081, 3016170326, 3003622639, 3043513123, 3013896610, 3014856521, 3013679558, 3003794634, 3032948391, 3007307487, 2434008, 3014848734, 2025816, 3003971136, 2022648, 3006254866, 3002663379, 3008483389, 3038761440, 3007603826, 3012933969, 3014233600, 3013596024, 3010082909, 3003630387 +357 more
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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.