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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 K152863
Device Name Portable ECG Monitor
Applicant
Contec Medical Systems Co.,Ltd
#112 Qinhuang W. St., Economic &
Technical Development Zone,
Qinhuangdao,  CN 066004
Applicant Contact XUEYONG LI
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact DIANA HONG
Regulation Number870.2340
Classification Product Code
DPS  
Date Received09/30/2015
Decision Date 06/22/2016
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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