510(k) K133360 ยท CAF Nebulizer (Direct Patient Interface)
AERONEB SOLO; AERONEB SOLO ADAPTER
| Applicant | Aerogen, Ltd., Galway, IE |
| Decision | Substantially Equivalent, Oct 17, 2014 |
| Received | Nov 1, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133360
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.