510(k) K203155 ยท CAF Nebulizer (Direct Patient Interface)
BreatheSuite MDI V1
| Applicant | Breathesuite, Inc., St. John'S, CA |
| Decision | Substantially Equivalent, Sep 17, 2021 |
| Received | Oct 22, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203155
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.