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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 K220095
Device Name ANNE Sleep
Applicant
Sibel, Inc.
6650 W Touhy Ave.
Niles,  IL  60714
Applicant Contact Peter Xu
Correspondent
Sibel, Inc.
6650 W Touhy Ave.
Niles,  IL  60714
Correspondent Contact Sarah Coughlin
Regulation Number868.2375
Classification Product Code
MNR  
Date Received01/12/2022
Decision Date 07/11/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT04643782
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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