Med-link Disposable ECG Cable and Leadwires— 510(k) K220447

Substantially Equivalent

Shenzhen Med-Link Electronics Tech Co., Ltd.

FDA 510(k) clearance K220447 for Med-link Disposable ECG Cable and Leadwires, Substantially Equivalent on 2022-06-28. Applicant: Shenzhen Med-Link Electronics Tech Co., Ltd..

Clearance details

Applicant: Shenzhen Med-Link Electronics Tech Co., Ltd.
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 2022-02-16
Decision date: 2022-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSA

product code DSA

Death: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.