510(k) K080391 ยท CAW Generator, Oxygen, Portable
DRIVE SOLSTICE OXYGEN CONCENTRATOR
| Applicant | Medical Depot, Appollo Beach FL, US |
| Decision | Substantially Equivalent, Mar 18, 2008 |
| Received | Feb 13, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080391
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2017 | Inovo, Inc PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S Terminated |
CAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.