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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K243981
Device Name Hexoskin Medical System (7100-00016)
Applicant
Carre Technologies, Inc.
5800 St. Denis, Suite 601
Montreal,  CA H2S 3L5
Applicant Contact Jean-François Roy
Correspondent
Carre Technologies, Inc.
5800 St. Denis, Suite 601
Montreal,  CA H2S 3L5
Correspondent Contact Jean-François Roy
Regulation Number870.2920
Classification Product Code
DXH  
Subsequent Product Code
BZQ  
Date Received12/23/2024
Decision Date 11/18/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT05970328
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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