510(k) K060497 ยท CAF Nebulizer (Direct Patient Interface)
BABYAIR
| Applicant | Promedic, Inc., Bonita Springs FL, US |
| Decision | Substantially Equivalent, Jul 11, 2006 |
| Received | Feb 24, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060497
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.