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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 K191417
Device Name Belun Ring
Applicant
Belun Technology Company Limited
Rm531b, Floor 5, Core Bldg. 2, 1 Science Park W. Ave.
Hk Science Park
Sha Tin,  HK
Applicant Contact Leung Lap Wai Lydia
Correspondent
Belun Technology Company Limited
Rm531b, Floor 5, Core Bldg. 2, 1 Science Park W. Ave.
Hk Science Park
Sha Tin,  HK
Correspondent Contact Leung Lap Wai Lydia
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/28/2019
Decision Date 10/10/2019
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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