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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 K211407
Device Name Belun Ring BLR-100X
Applicant
Belun Technology Company Limited
Unit 218, 2/F, Core Building 2, No. 1 Science Park
West Avenue, Hong Kong Science Park
Sha Tin,  CN
Applicant Contact Leung Lap Wai Lydia
Correspondent
Belun Technology Company Limited
Unit 218, 2/F, Core Building 2, No. 1 Science Park
West Avenue, Hong Kong Science Park
Sha Tin,  CN
Correspondent Contact Leung Lap Wai Lydia
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/06/2021
Decision Date 10/21/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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