ECG Cables and Leadwires— 510(k) K201359

Substantially Equivalent

Xinkang Medical Instrument Co. , Ltd.

FDA 510(k) clearance K201359 for ECG Cables and Leadwires, Substantially Equivalent on 2020-10-01. Applicant: Xinkang Medical Instrument Co. , Ltd..

Clearance details

Applicant: Xinkang Medical Instrument Co. , Ltd.
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 2020-05-21
Decision date: 2020-10-01
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.