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510(k) K234110

Belun Ring BLR-200 (BLR-200) by Belun Technology Company Limited — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2024
Date Received
December 27, 2023
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

  • K222579 — Belun Sleep System BLS-100 (February 23, 2023)
  • K211407 — Belun Ring BLR-100X (October 21, 2021)
  • K191417 — Belun Ring (October 10, 2019)
  • K180174 — Belun Ring (May 29, 2018)

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