510(k) K000401 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
VAPOTHERM, MODEL 2000I
| Applicant | Vapotherm, Inc., Annapolis MD, US |
| Decision | Substantially Equivalent, Aug 24, 2000 |
| Received | Feb 7, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000401
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.