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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K180432
Device Name AI-ECG Platform
Applicant
Shenzhen Carewell Electronics., Ltd
2/F, Building 1, Glory Medical Industrial Park
NO.2, Baolong Road 5, Longgang
Shenzhen,  CN 518116
Applicant Contact Chang Liu
Correspondent
FDA Regulatory and Quality Systems Consultant
31853 Cedar Road
Mayfield Heights,  OH  44124 -4445
Correspondent Contact Arthur Goddard
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Code
DPS  
Date Received02/20/2018
Decision Date 11/19/2018
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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