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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
Sibel Inc.
6650 W. Touhy Ave.
Niles,  IL  60714
Applicant Contact Peter Xu
Sibel Inc.
6650 W. Touhy Ave.
Niles,  IL  60714
Correspondent Contact Sarah Coughlin
Regulation Number868.2375
Classification Product Code
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