The following data is part of a premarket notification filed by Fisher & Paykel Healthcare Ltd with the FDA for F&p Visairo Niv Mask Range.
| Device ID | K203449 |
| 510k Number | K203449 |
| Device Name: | F&P Visairo NIV Mask Range |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | Fisher & Paykel Healthcare Ltd 15 Maurice Paykel Place, East Tamaki Auckland, NZ 2013 |
| Contact | Reena Daken |
| Correspondent | Reena Daken Fisher & Paykel Healthcare Ltd 15 Maurice Paykel Place, East Tamaki Auckland, NZ 2013 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-23 |
| Decision Date | 2021-04-14 |