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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K221282
Device Name Empatica Health Monitoring Platform
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 Number870.2700
Classification Product Code
DQA  
Subsequent Product Codes
DRG   FLL   GZO   LEL  
Date Received05/03/2022
Decision Date 11/20/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT04964609
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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