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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 K171360
Device Name CONTEC™ Electrocardiograph
Applicant
Contec Medical Systems Co., LTD.
No. 112 QinHuang West Street
Economic & Technical Development Zone
qinhuangdao,  CN 066012
Applicant Contact xueyong li
Correspondent
Beijing Believe Technology Service Co., Ltd.
5-402, Building #27, YangGuangYiShang, No.56,
LiangXiang East Rd.,
fangshan dist,beijing,,  CN 102401
Correspondent Contact ray wang
Regulation Number870.2340
Classification Product Code
DPS  
Date Received05/09/2017
Decision Date 01/22/2018
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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