510(k) clearances

AViTA Pulse Oximeter (SP62B)

Avita Corporation · Cardiovascular

K242455Substantially EquivalentTraditionalDQA
Open FDA's page for this record
Third party flag
N
City
New Taipei City
Advisory committee description
Cardiovascular
Address 1
9f, #78, Sec.1, Kwang Fu Rd., Sanchong Dist.,
Statement or summary
Summary
Product code
DQA
Zip code
24158
Applicant
Avita Corporation
Decision date
2025-02-19
Decision code
SESE
Country code
TW
Device name
AViTA Pulse Oximeter (SP62B)
Advisory committee
CV
Contact
Maggie Chao
K number
K242455
Date received
2024-08-19
Review advisory committee
AN
Postal code
24158
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
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

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.