DeviceClearance

OX-GEN FLEXIBLE O2 GENERATION SYSTEM, MODEL 6-OX-03— 510(k) K033863

Substantially Equivalent

Ox-Gen, Inc.

FDA 510(k) clearance K033863 for OX-GEN FLEXIBLE O2 GENERATION SYSTEM, MODEL 6-OX-03, Substantially Equivalent on 2005-08-22. Applicant: Ox-Gen, Inc.. Device class: 2.

Clearance details

Applicant
Ox-Gen, Inc.
Product code
Code CAW
Device class
Class 2
Regulation
21 CFR 868.5440
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Boise, ID, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code CAW

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Adverse events under product code CAW

product code CAW
Death
204
Injury
573
Malfunction
1,400
Other
6
Total
2,183

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.