510(k) K170367 ยท MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti
| Applicant | Fisher and Paykel Healthcare Limited, Auckland, NZ |
| Decision | Substantially Equivalent, Aug 24, 2017 |
| Received | Feb 6, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170367
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.