510(k) K020386 ยท CAW Generator, Oxygen, Portable
INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02
| Applicant | Invacare Corp., Elyria OH, US |
| Decision | Substantially Equivalent, Jul 2, 2002 |
| Received | Feb 6, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020386
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 24, 2014 | Invacare Corporation Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per box. Terminated |
CAW | None listed |
| Dec 12, 2014 | Invacare Corporation Invacare Perfecto 2 V Oxygen Concentrator
The finished device is packaged as a single unit.
The service part contains a single pair of sieve beds; one pair of sieve beds is used in a single finished Terminated |
CAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.