The following data is part of a premarket notification filed by Fisher & Paykel Healthcare Limited with the FDA for F&p Nivairo Rt047 Vented Hospital Full Face Mask, Anti-asphyxiation Valve Version.
| Device ID | K191624 |
| 510k Number | K191624 |
| Device Name: | F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version |
| Classification | Ventilator, Continuous, Minimal Ventilatory Support, Facility Use |
| Applicant | Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place Auckland, NZ 2013 |
| Contact | Nicholas Yap |
| Correspondent | Reena Daken Fisher & 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 | 2019-06-18 |
| Decision Date | 2020-03-09 |