510(k) K052941 ยท CAF Nebulizer (Direct Patient Interface)
I-NEB INSIGHT AAD SYSTEM
| Applicant | Profile Therapeutics Plc, Murrysville PA, US |
| Decision | Substantially Equivalent, Dec 9, 2005 |
| Received | Oct 20, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052941
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.