The following data is part of a premarket notification filed by Fisher & Paykel Healthcare Ltd with the FDA for F&p Evora Full Face Mask.
| Device ID | K212371 |
| 510k Number | K212371 |
| Device Name: | F&P Evora Full Face Mask |
| Classification | Ventilator, Non-continuous (respirator) |
| 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 | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-30 |
| Decision Date | 2022-03-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09420012472533 | K212371 | 000 |
| 09420012461742 | K212371 | 000 |
| 09420012461766 | K212371 | 000 |
| 09420012461780 | K212371 | 000 |
| 09420012461803 | K212371 | 000 |
| 09420012461827 | K212371 | 000 |
| 09420012461834 | K212371 | 000 |
| 09420012471802 | K212371 | 000 |
| 09420012472519 | K212371 | 000 |
| 09420012472526 | K212371 | 000 |
| 09420012461711 | K212371 | 000 |