COMPATIBILITY ECG TRUNK CABLES— 510(k) K043572

Name: FDA 510(k) clearance K043572
Creator: U.S. Food and Drug Administration
Published: 2005-02-22

Substantially Equivalent

Datex-Ohmeda

FDA 510(k) clearance K043572 for COMPATIBILITY ECG TRUNK CABLES, Substantially Equivalent on 2005-02-22. Applicant: Datex-Ohmeda. Device class: 2.

Clearance details

Applicant: Datex-Ohmeda
Product code: Product code DSA
Device class: Class 2
Regulation: 21 CFR 870.2900
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 ↗

Recent devices under product code DSA

view all

K262816 — EXG PulseLinQ Cables (EXGPL)2026-10-30
K254114 — Baylis Connector Cable2026-01-18
K252827 — IBP cable Becton Dickinson (2606488) +5 more2025-12-01
K251669 — IBP transducer adapter cable, Argon/BD/Ohmeda, 2m +8 more2025-09-30
K242986 — SpO2 Extension Cable2025-05-02

More clearances from Datex-Ohmeda

view all

K231964 — Novii+ Wireless Patch System2023-12-08
K131945 — GE DATEX-OHMEDA AVANCE CS22013-08-08
K122445 — AESPIRE 7900, AESPIRE VIEW2012-10-12
K111116 — ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-0002011-09-09
K071142 — GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM2007-06-06

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.