DATEX-OHMEDA INOVENT DELIVERY SYSTEM— 510(k) K000186

Substantially Equivalent

Datex-Ohmeda

FDA 510(k) clearance K000186 for DATEX-OHMEDA INOVENT DELIVERY SYSTEM, Substantially Equivalent on 2000-02-10. Applicant: Datex-Ohmeda.

Clearance details

Applicant: Datex-Ohmeda
Product code: Code MRN
Advisory panel: Anesthesiology
Date received: 2000-01-14
Decision date: 2000-02-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Madison, WI, US

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Adverse events under product code MRN

product code MRN

Death: 9
Malfunction: 910
Total: 919

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.