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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Sleep Assessment
510(k) Number K252981
Device Name EmbraceMini
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 Number882.5050
Classification Product Code
LEL  
Date Received09/17/2025
Decision Date 12/22/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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