INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02
FDA 510(k) clearance K020386 · decided 2002-07-02
Clearance details
- K-number
- K020386
- Device name
- INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02
- Applicant
- Invacare Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-02-06
- Decision date
- 2002-07-02
- Days to decision
- 146 days
- Clearance type
- Traditional
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Elyria, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per bo recall (Z-0872-2015) | Invacare Corporation | 2014-12-24 |
| Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single unit recall (Z-0577-2015) | Invacare Corporation | 2014-12-12 |