510(k) K854374 ยท CAW Generator, Oxygen, Portable
OXYGEN CONCENTRATOR, MODEL BX-5000
| Applicant | Healthdyne, Inc., Marietta GA, US |
| Decision | Substantially Equivalent, Jan 3, 1986 |
| Received | Oct 30, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854374
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.