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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Network And Communication, Physiological Monitors
510(k) Number K261367
Device Name Corsano CardioWatch 287-2 System
Applicant
Corsano Health B.V.
Waldorpstraat 5
The Hague,  NL 2521
Applicant Contact Peter STAS
Correspondent
Corsano Health B.V.
Waldorpstraat 5
The Hague,  NL 2521
Correspondent Contact Peter STAS
Regulation Number870.2300
Classification Product Code
MSX  
Subsequent Product Codes
BZG   BZQ   DQA   DRG   DXN  
FLL   FRI   LEL  
Date Received04/27/2026
Decision Date 07/26/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
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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