510(k) K203210 ยท CAW Generator, Oxygen, Portable
Invacare Platinum 5NXG Oxygen Concentrator
| Applicant | Invacare Corporation, Elyria OH, US |
| Decision | Substantially Equivalent, Apr 12, 2021 |
| Received | Oct 30, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203210
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 10, 2022 | Invacare Corporation Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model) Open, Classified |
CAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.