MODIFICATION TO VENTURE IHO 100 COMPLETE HOME OXYGEN SYSTEM— 510(k) K983777
Substantially EquivalentInvacare Corp.
FDA 510(k) clearance K983777 for MODIFICATION TO VENTURE IHO 100 COMPLETE HOME OXYGEN SYSTEM, Substantially Equivalent on 1998-12-18. Applicant: Invacare Corp.. Device class: 2.
Clearance details
- Applicant
- Invacare Corp.
- Product code
- Product 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
- Elyria, OH, US
Recent devices under product code CAW
view allMore clearances from Invacare Corp.
view allAdverse 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.