510(k) K231380 · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
AirLife DuoTherm Humidification System
| Applicant | Vyaire Medical, Inc., Mettawa IL, US |
| Decision | Substantially Equivalent, Aug 10, 2023 |
| Received | May 12, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231380
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.