510(k) clearances

Pulse Oximeter ( PO2, PO2A, PO2B)

Shenzhen Viatom Technology Co., Ltd. · Cardiovascular

K242876Substantially EquivalentTraditionalDQA
Open FDA's page for this record
Third party flag
N
City
Shenzhen
Advisory committee description
Cardiovascular
Address 1
501, Bldg. B, Ganghongji High-Tech Intelligent Industrial
Address 2
Park, #1008 Songbai Rd. Xili St., Nanshan District
Statement or summary
Summary
Product code
DQA
Zip code
518055
Applicant
Shenzhen Viatom Technology Co., Ltd.
Decision date
2025-02-28
Decision code
SESE
Country code
CN
Device name
Pulse Oximeter ( PO2, PO2A, PO2B)
Advisory committee
CV
Contact
Lynne Li
K number
K242876
Date received
2024-09-23
Review advisory committee
AN
Postal code
518055
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.