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510(k) K191417

Belun Ring by Belun Technology Company Limited — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2019
Date Received
May 28, 2019
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 Belun Technology Company Limited

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  • K211407 — Belun Ring BLR-100X (October 21, 2021)
  • K180174 — Belun Ring (May 29, 2018)

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