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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 K240251
Device Name ANNE Chest
Applicant
Sibel Health Inc.
2017 N Mendell
Unit 2SE
Chicago,  IL  60614
Applicant Contact Sarah Coughlin
Correspondent
Sibel Health Inc.
2017 N Mendell
Unit 2SE
Chicago,  IL  60614
Correspondent Contact Sarah Coughlin
Regulation Number870.2910
Classification Product Code
DRG  
Subsequent Product Codes
BZQ   FLL   KMI   MWI   MWJ  
Date Received01/30/2024
Decision Date 06/03/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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