DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE— 510(k) K043276

Name: FDA 510(k) clearance K043276
Creator: U.S. Food and Drug Administration
Published: 2004-12-23

Substantially Equivalent

Datex-Ohmeda

FDA 510(k) clearance K043276 for DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE, Substantially Equivalent on 2004-12-23. Applicant: Datex-Ohmeda. Device class: 2.

Clearance details

Applicant: Datex-Ohmeda
Product code: Code MHX
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 2004-11-26
Decision date: 2004-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Needham, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MHX

product code MHX

Death: 580
Injury: 2,441
Malfunction: 12,655
Other: 3
Total: 15,679

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 →

Recalls naming K043276

K-number listed on FDA's recall record

Z-2068-2014 — DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.Class I·Terminated·GE Healthcare, LLC·20140611

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K043276.

Data sourced from openFDA. This site is unofficial and independent of the FDA.