DATEX-OHMEDA HMEF 500— 510(k) K021265

Substantially Equivalent

Datex-Ohmeda

FDA 510(k) clearance K021265 for DATEX-OHMEDA HMEF 500, Substantially Equivalent on 2002-08-30. Applicant: Datex-Ohmeda.

Clearance details

Applicant: Datex-Ohmeda
Product code: Code CAH
Advisory panel: Anesthesiology
Date received: 2002-04-22
Decision date: 2002-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Needham, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAH

product code CAH

Death: 7
Total: 7

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.