510(k) K182573 ยท CAF Nebulizer (Direct Patient Interface)
Hailie Sensor
| Applicant | Adherium (Nz), Ltd., Auckland, NZ |
| Decision | Substantially Equivalent, Jun 7, 2019 |
| Received | Sep 18, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182573
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.