CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE)— 510(k) K120010

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

2012-01-03

Decision date

2012-01-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Shenzhen, Guangdong, CN

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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 →