The following data is part of a premarket notification filed by Fisher And Paykel Healthcare Limited with the FDA for 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, Niv.
| Device ID | K170367 |
| 510k Number | K170367 |
| Device Name: | 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, Niv |
| Classification | Ventilator, Continuous, Minimal Ventilatory Support, Facility Use |
| Applicant | Fisher And Paykel Healthcare Limited 15 Maurice Paykel Place Auckland, NZ 2013 |
| Contact | Danica Tung |
| Correspondent | Danica Tung Fisher And Paykel Healthcare Limited 15 Maurice Paykel Place Auckland, NZ 2013 |
| Product Code | MNT |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-06 |
| Decision Date | 2017-08-24 |