Cleared Traditional

Med-link Disposable ECG Cable and Leadwires

K220447 · Shenzhen Med-Link Electronics Tech Co., Ltd. · Cardiovascular
Jun 2022
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K220447 is an FDA 510(k) clearance for the Med-link Disposable ECG Cable and Leadwires, a Cable, Transducer And Electrode, Patient, (including Connector) (Class II — Special Controls, product code DSA), submitted by Shenzhen Med-Link Electronics Tech Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 28, 2022, 132 days after receiving the submission on February 16, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2900.

Submission Details

510(k) Number K220447 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 2022
Decision Date June 28, 2022
Days to Decision 132 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSA — Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2900

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