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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrocardiograph
510(k) Number K200036
Device Name AI-ECG Tracker
Shenzhen Carewell Electronics Co., Ltd.
Floor 4, BLD 9, Baiwangxin High-Tech Industrial Park
Songbai Road, Xili Street
Shenzhen,  CN 518108
Applicant Contact Chang Liu
FDA Regulatory and Quality Systems Consultant
31853 Cedar Road
Mayfield Heights,  OH  44124 -4445
Correspondent Contact Arthur Goddard
Regulation Number870.2340
Classification Product Code
Subsequent Product Code
Date Received01/08/2020
Decision Date 03/20/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No