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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
Predetermined Change
Control Plan Authorized		 No
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