510(k) K180474 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
TNI softFlow 50
| Applicant | Tni Medical AG, Wuerzburg, DE |
| Decision | Substantially Equivalent, Oct 18, 2018 |
| Received | Feb 22, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180474
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.