DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE03 AND LCANE03A SOFTWARE— 510(k) K041790

Name: FDA 510(k) clearance K041790
Creator: U.S. Food and Drug Administration
Published: 2004-07-23

Substantially Equivalent

Datex-Ohmeda

FDA 510(k) clearance K041790 for DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE03 AND LCANE03A SOFTWARE, Substantially Equivalent on 2004-07-23. 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: 2004-07-02
Decision date: 2004-07-23
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 →

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