510(k) K102454 ยท CAF Nebulizer (Direct Patient Interface)
I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM
| Applicant | Respironics Respiratory Drug Delivery (Uk) , Ltd., Bonita Springs FL, US |
| Decision | Substantially Equivalent, Oct 25, 2011 |
| Received | Aug 27, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102454
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.