DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSORIES— 510(k) K031781

Substantially Equivalent

Datex-Ohmeda

FDA 510(k) clearance K031781 for DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSORIES, Substantially Equivalent on 2003-06-25. Applicant: Datex-Ohmeda.

Clearance details

Applicant: Datex-Ohmeda
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2003-06-10
Decision date: 2003-06-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Needham, MA, US

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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.