510(k) K080230 ยท CAF Nebulizer (Direct Patient Interface)
NEB-U-MASK SYSTEM, MODELS 1895, 1896
| Applicant | Teleflexmedical, Inc., Bonita Springs FL, US |
| Decision | Substantially Equivalent, Jun 9, 2008 |
| Received | Jan 30, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080230
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.