510(k) K063125 ยท CAH Filter, Bacterial, Breathing-Circuit
FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME)
| Applicant | Arc Medical, Inc., Bonita Springs FL, US |
| Decision | Substantially Equivalent, Apr 13, 2007 |
| Received | Oct 13, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063125
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.