ECG Cable— 510(k) K191428

Substantially Equivalent

Shenzhen Changke Connect Electronics Co., Ltd.

FDA 510(k) clearance K191428 for ECG Cable, Substantially Equivalent on 2019-11-27. Applicant: Shenzhen Changke Connect Electronics Co., Ltd..

Clearance details

Applicant: Shenzhen Changke Connect Electronics Co., Ltd.
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 2019-05-29
Decision date: 2019-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Longgang District, 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.