510(k) K042991 ยท CAF Nebulizer (Direct Patient Interface)
I-NEB AAD SYSTEM
| Applicant | Profile Therapeutics Plc, Murrysville PA, US |
| Decision | Substantially Equivalent, Sep 23, 2005 |
| Received | Nov 1, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042991
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.