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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K234110
Device Name Belun Ring BLR-200 (BLR-200)
Applicant
Belun Technology Company Limited
Flat/Rm 225b, 2/F, Bldg. 1w, Phase One
Hong Kong Science Park, Pak Shek Kok, N.T.
Hong Kong,  HK
Applicant Contact Lap Wai Lydia Leung
Correspondent
Belun Technology Company Limited
Flat/Rm 225b, 2/F, Bldg. 1w, Phase One
Hong Kong Science Park, Pak Shek Kok, N.T.
Hong Kong,  HK
Correspondent Contact Lap Wai Lydia Leung
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/27/2023
Decision Date 10/11/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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