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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrocardiograph software for over-the-counter use
510(k) Number K230292
Device Name Samsung ECG Monitor Application with Irregular Heart Rhythm Notification
Applicant
Samsung Electronics Co., Ltd
129 Samsung-ro, Yeoungton-gu
Suwon-si,  KR
Applicant Contact Hon Pak
Correspondent
Samsung Research America
665 Clyde Avenue
Mountain View,  CA  94043
Correspondent Contact Matthew Wiggins
Regulation Number870.2345
Classification Product Code
QDA  
Subsequent Product Code
QDB  
Date Received02/02/2023
Decision Date 05/02/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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