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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cable, transducer and electrode, patient, (including connector)
510(k) Number K172797
Device Name ECG Cable/Leadwires
Applicant
Shenzhen Coreray Technology., Ltd
ChuangYe Technology Park,1th Dong Huan Road,
Longhua New District
Shenzhen,  CN 518109
Applicant Contact Simon Fan
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
Shizhou zhong Road 55#,Na
Shenzhen,  CN 518100
Correspondent Contact Field Fu
Regulation Number870.2900
Classification Product Code
DSA  
Date Received09/15/2017
Decision Date 02/28/2018
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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