510(k) K191010 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Palladium High Flow Therapy System
| Applicant | Vapotherm, Inc., Exeter NH, US |
| Decision | Substantially Equivalent, Oct 10, 2019 |
| Received | Apr 16, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191010
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.