Unimed Disposable ECG lead wires— 510(k) K142489

Substantially Equivalent

Unimed Medical Supplies, Inc.

FDA 510(k) clearance K142489 for Unimed Disposable ECG lead wires, Substantially Equivalent on 2014-11-04. Applicant: Unimed Medical Supplies, Inc..

Clearance details

Applicant: Unimed Medical Supplies, Inc.
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 2014-09-04
Decision date: 2014-11-04
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.