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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transmitters and receivers, physiological signal, radiofrequency
510(k) Number K223711
Device Name ANNE One
Applicant
Sibel Health Inc.
6650 W Touhy Ave.
Niles,  IL  60714
Applicant Contact Sarah Coughlin
Correspondent
Sibel Health Inc.
6650 W Touhy Ave.
Niles,  IL  60714
Correspondent Contact Sarah Coughlin
Regulation Number870.2910
Classification Product Code
DRG  
Subsequent Product Codes
DQA   FLL   KMI   MWI   MWJ  
Date Received12/12/2022
Decision Date 08/10/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT05693168
Reviewed by Third Party No
Combination Product No
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