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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 K232548
Device Name Corsano CardioWatch 287-2 System
Applicant
Corsano Health B.V.
Wilhelmina Van Pruisenweg 35
's-Gravenhage,  NL 2595 AN
Applicant Contact Peter Stas
Correspondent
Corsano Health B.V.
Wilhelmina Van Pruisenweg 35
's-Gravenhage,  NL 2595 AN
Correspondent Contact Peter Stas
Regulation Number870.2300
Classification Product Code
MSX  
Subsequent Product Codes
BZG   BZQ   DQA   DRG   DXN  
FLL   FRI  
Date Received08/23/2023
Decision Date 03/22/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT05542732
NCT05899959
Reviewed by Third Party No
Combination Product No
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