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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 K181861
Device Name Embrace
Applicant
Empatica Srl
Via Stendhal 36
Milano,  IT 20144
Applicant Contact Simone Tognetti
Correspondent
Rakesh Lal
318 Rindge Ave 407
Cambridge,  MA  02140
Correspondent Contact Rakesh Lal
Regulation Number882.1580
Classification Product Code
POS  
Date Received07/12/2018
Decision Date 12/20/2018
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
Recalls CDRH Recalls
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