ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM— 510(k) K014078
Substantially EquivalentOn Site Gas Systems, Inc.
FDA 510(k) clearance K014078 for ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM, Substantially Equivalent on 2002-01-08. Applicant: On Site Gas Systems, Inc..
Clearance details
- Applicant
- On Site Gas Systems, Inc.
- Product code
- Code CAW
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New Britain, CT, US
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.