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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 K131900
Device Name CONTEC ELECTROCARDIOGRAPH
Applicant
Contec Medical System Co., Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Applicant Contact Diana Hong
Correspondent
Contec Medical System Co., Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number870.2340
Classification Product Code
DPS  
Date Received06/25/2013
Decision Date 03/05/2014
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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