510(k) K191624 ยท MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version
| Applicant | Fisher & Paykel Healthcare Limited, Auckland, NZ |
| Decision | Substantially Equivalent, Mar 9, 2020 |
| Received | Jun 18, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191624
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.