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

Clearance details

Applicant

Shenzhen Med-Link Electronics Tech Co., Ltd.

Product code

Product code DSA

Device class

Class 2

Regulation

21 CFR 870.2900

Advisory panel

Cardiovascular

Date received

2022-02-16

Decision date

2022-06-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Shenzhen, CN

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• K251160 — Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)2026-01-08
• K220448 — Disposable Non-invasive EEG Sensor2023-01-19
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• K210441 — Incontinence Probe2021-09-17
• K202743 — Med-Link Temp-pulse Oximeter2021-03-01

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 →