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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 K232915
Device Name EpiMonitor
Applicant
Empatica Srl
Via Stendhal, 36
Milan,  IT 20144
Applicant Contact Alberto Poli
Correspondent
Empatica Srl
Via Stendhal, 36
Milan,  IT 20144
Correspondent Contact Alberto Poli
Regulation Number882.1580
Classification Product Code
POS  
Subsequent Product Codes
FLL   LEL  
Date Received09/19/2023
Decision Date 02/15/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT03207685
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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