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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
Applicant
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
Correspondent
FDA Regulatory and Quality Systems Consultant
31853 Cedar Road
Mayfield Heights,  OH  44124 -4445
Correspondent Contact Arthur Goddard
Regulation Number870.2340
Classification Product Code
DPS  
Subsequent Product Code
DQK  
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
Predetermined Change
Control Plan Authorized		 No
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