510(k) K102240 ยท CAF Nebulizer (Direct Patient Interface)
NIVO NEBULIZER SYSTEM
| Applicant | Aerogen Ireland, Ltd., Galway, IE |
| Decision | Substantially Equivalent, Nov 10, 2010 |
| Received | Aug 9, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K102240
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.