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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 K172935
Device Name Embrace
Empatica Srl
Via Stendhal 36
Milano,  IT 20144
Applicant Contact Simone Tognetti
Rakesh Lal
318 Rindge Ave 407
Cambridge,  MA  02140
Correspondent Contact Rakesh Lal
Regulation Number882.1580
Classification Product Code
Date Received09/26/2017
Decision Date 01/26/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No