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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 K200026
Device Name Disposable ECG Cable
Applicant
Shenzhen Changke Connect Electronics Co., Ltd.
A2-4th floor of Xiang dali Technology Park,
No.87 of HengPing Road, Henggang,
Longgang District, Shenzhen,  CN 518000
Applicant Contact Yahui Zhou
Correspondent
Chonconn Medical Device Consulting Co., Ltd.
No. A415, Block A, NanShan Medical Devices Industrial Park
Nanshan District,
Shenzhen,  CN 518067
Correspondent Contact Kevin Wang
Regulation Number870.2900
Classification Product Code
DSA  
Date Received01/06/2020
Decision Date 05/12/2020
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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