OHMEDA - LOW FLOW FLOWMETER— 510(k) K910316

Substantially Equivalent

Ohmeda Medical

FDA 510(k) clearance K910316 for OHMEDA - LOW FLOW FLOWMETER, Substantially Equivalent on 1991-04-12. Applicant: Ohmeda Medical.

Clearance details

Applicant: Ohmeda Medical
Product code: Code CAX
Advisory panel: Anesthesiology
Date received: 1991-01-24
Decision date: 1991-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAX

product code CAX

Death: 3
Other: 1
Total: 4

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.