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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
Samsung Electronics Co., Ltd
129 Samsung-ro, Yeoungton-gu
Suwon-si,  KR
Applicant Contact Hon Pak
Samsung Research America
665 Clyde Avenue
Mountain View,  CA  94043
Correspondent Contact Matthew Wiggins
Regulation Number870.2345
Classification Product Code
Subsequent Product Code
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