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510(k) K203812

Oxyfit Pulse Oximeter by Shenzhen Viatom Technology Co., Ltd. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2022
Date Received
December 28, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type

Other clearances by Shenzhen Viatom Technology Co., Ltd.

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  • K191088 — Checkme O2 Pulse Oximeter (December 2, 2019)
  • K190207 — Blood Pressure Monitor (August 19, 2019)

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  • K251693 — Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensor (November 18, 2025)
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