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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilatory effort recorder
510(k) Number K222579
Device Name Belun Sleep System BLS-100
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 Number868.2375
Classification Product Code
MNR  
Date Received08/25/2022
Decision Date 02/23/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT04885062
Reviewed by Third Party No
Combination Product No
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