510(k) K251615 ยท SFP Ventilator-Compatible Nebulizer
Aerogen Pro-X1 Controller System
| Applicant | Aerogen, Ltd., Galway, IE |
| Decision | Substantially Equivalent, Sep 2, 2025 |
| Received | May 27, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251615
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.