510(k) K220447

Med-link Disposable ECG Cable and Leadwires by Shenzhen Med-Link Electronics Tech Co., Ltd. — Product Code DSA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2022
Date Received
February 16, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Device Class
Class II
Regulation Number
870.2900
Review Panel
CV
Submission Type