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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
Predetermined Change
Control Plan Authorized		 No
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