COMPATIBILITY ECG TRUNK CABLES— 510(k) K043572

Substantially Equivalent

Datex-Ohmeda

FDA 510(k) clearance K043572 for COMPATIBILITY ECG TRUNK CABLES, Substantially Equivalent on 2005-02-22. Applicant: Datex-Ohmeda.

Clearance details

Applicant: Datex-Ohmeda
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 2004-12-27
Decision date: 2005-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Needham, MA, US

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.