510(k) K232507 · CAF Nebulizer (Direct Patient Interface)
Aerogen®Solo Nebulizer System
| Applicant | Aerogen, Ltd., Dangan Galway, IE |
| Decision | Substantially Equivalent, May 10, 2024 |
| Received | Aug 18, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232507
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.