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. Device class: 1.

Clearance details

Applicant
Ohmeda Medical
Product code
Code CAX
Device class
Class 1
Regulation
21 CFR 868.2340
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Columbia, MD, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code CAX

product code CAX
Death
3
Other
1
Total
4

Source: openFDA MAUDE database, through . 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.