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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 K201168
Device Name ECG Monitor App
Applicant
Samsung Electronics Co., Ltd
129, Samsung-ro, Yeongtong-gu,
Suwon-si,  KR 16677
Applicant Contact Taejong Jay Yang
Correspondent
Samsung Electronics Co., Ltd
665 Clyde Avenue
Mountain View,  CA  94043
Correspondent Contact Matthew Wiggins
Regulation Number870.2345
Classification Product Code
QDA  
Date Received05/01/2020
Decision Date 08/04/2020
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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