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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
Predetermined Change
Control Plan Authorized		 No
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