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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 K170536
Device Name ECG Disposable Lead Wire
Applicant
APK Technology Co., Ltd.
6floor, B2 Bldg., Industry Of Hengfeng
Hezhou, Xixiang, Bao'An Distric
Shenzhen,  CN 518126
Applicant Contact Caifang Wang
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number870.2900
Classification Product Code
DSA  
Date Received02/23/2017
Decision Date 04/24/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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