510(k) K200063 ยท CAF Nebulizer (Direct Patient Interface)
AeroEclipse* ONE BAN
| Applicant | Trudell Medical International, London, CA |
| Decision | Substantially Equivalent, Jul 17, 2020 |
| Received | Jan 13, 2020 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K200063
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.