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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
FOIA Releasable 510(k) K222579
Device Name Belun Sleep System BLS-100
Applicant
Belun Technology Company Limited
Unit 218, 2/F, Core Bldg. 2, # 1 Science Park
West Ave., Hong Kong Science Park
Sha Tin,  CN
Applicant Contact Leung Lap Wai Lydia
Correspondent
Belun Technology Company Limited
Unit 218, 2/F, Core Bldg. 2, # 1 Science Park
West Ave., 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
Predetermined Change
Control Plan Authorized		 No
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