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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K242737
Device Name Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal
Applicant
Empatica S.R.L.
Via Stendhal, 36
Milan,  IT 20144
Applicant Contact Alberto Poli
Correspondent
Empatica S.R.L.
Via Stendhal, 36
Milan,  IT 20144
Correspondent Contact Alberto Poli
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
BZQ   DQA   DRG   FLL   GZO  
LEL  
Date Received09/11/2024
Decision Date 06/06/2025
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		 Yes
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