510(k) K250022 ยท CAF Nebulizer (Direct Patient Interface)
HeroTracker Sense
| Applicant | Voluntis, Paris, FR |
| Decision | Substantially Equivalent, Jun 30, 2025 |
| Received | Jan 3, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250022
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.