510(k) K223551 · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Sterile Water for Inhalation in 1L Flexoval ® bottles.
| Applicant | Hometa, Inc., Albany NY, US |
| Decision | Substantially Equivalent, Aug 3, 2023 |
| Received | Nov 25, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223551
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.