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

Substantially Equivalent

Datex-Ohmeda

Clearance details

Applicant: Datex-Ohmeda
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2004-07-02
Decision date: 2004-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Needham, MA, US

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.