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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Physiological Signal Based Seizure Monitoring System
510(k) Number K250515
Device Name EpiMonitor
Applicant
Empatica S.R.L.
Via Stendhal, 36
Milano,  IT 20144
Applicant Contact Alberto Poli
Correspondent
Empatica S.R.L.
Via Stendhal, 36
Milano,  IT 20144
Correspondent Contact Alberto Poli
Regulation Number882.1580
Classification Product Code
POS  
Date Received02/21/2025
Decision Date 06/19/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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