The following data is part of a premarket notification filed by Fisher & Paykel Healthcare Ltd. with the FDA for F&p Evora Nasal Mask Nasal A Model (small, Medium, Large, Wide), F&p Evora Nasal Mask Nasal Fit Pack/ Sml (small/medium/large) A Model, F&p Evora Nasal Mask Nasal Sleep Lab (small, Medium, Large, Wide), F&p Evora Nasal Mask Nasal Fit Pack / Sml (smal.
| Device ID | K200089 |
| 510k Number | K200089 |
| Device Name: | F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Smal |
| 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 | 2020-01-15 |
| Decision Date | 2020-06-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09420012460103 | K200089 | 000 |
| 09420012460097 | K200089 | 000 |
| 09420012460080 | K200089 | 000 |
| 09420012460073 | K200089 | 000 |
| 09420012459930 | K200089 | 000 |
| 09420012459923 | K200089 | 000 |
| 09420012459916 | K200089 | 000 |
| 09420012459909 | K200089 | 000 |
| 09420012459893 | K200089 | 000 |