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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 K220447
Device Name Med-link Disposable ECG Cable and Leadwires
Applicant
Shenzhen Med-link Electronics Tech Co., Ltd.
4th and 5th Floor, Building Two, Hualian Industrial Zone,
Xinshi Community, Dalang Street
Shenzhen,  CN 518109
Applicant Contact Yi Liu
Correspondent
Shenzhen Med-link Electronics Tech Co., Ltd.
4th and 5th Floor, Building Two, Hualian Industrial Zone,
Xinshi Community, Dalang Street
Shenzhen,  CN 518109
Correspondent Contact Yi Liu
Regulation Number870.2900
Classification Product Code
DSA  
Date Received02/16/2022
Decision Date 06/28/2022
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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