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

Substantially Equivalent

Shenzhen Med-Link Electronics Tech Co., Ltd.

FDA 510(k) clearance K120010 for CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE), Substantially Equivalent on 2012-01-19. 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: 2012-01-03
Decision date: 2012-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, Guangdong, CN

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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.