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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 K170954
Device Name Portable ECG Monitor
CONTEC Medical Systems Co.,Ltd
No.112 Qinhuang West Street, Economic& Technical Development
qinhuangdao,  CN 066004
Applicant Contact xueyong li
Mid-Link Consulting Co.,Ltd
P.O. Box 120-119
shanghai,  CN 200120
Correspondent Contact diana hong
Regulation Number870.2340
Classification Product Code
Date Received03/31/2017
Decision Date 05/30/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No