510(k) K884563 ยท CAW Generator, Oxygen, Portable
OXYGEN CONCENTRATOR W/CONCENTRATION 3LPM 93% +/-3%
| Applicant | Ivex Medical, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, Apr 26, 1989 |
| Received | Oct 31, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884563
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.