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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
Predetermined Change
Control Plan Authorized		 No
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