The following data is part of a premarket notification filed by Fisher & Paykel Healthcare Ltd. with the FDA for F&p Vitera Mask Full Face A Model (small, Medium, Large), F&p Vitera Mask Full Face Sleep Lab Model (small, Medium, Large).
| Device ID | K190713 |
| 510k Number | K190713 |
| Device Name: | F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large) |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | Fisher & Paykel Healthcare Ltd. 15 Maurice Paykel Place, East Tamaki Auckland, NZ 2013 |
| Contact | Masar Mohammad |
| Correspondent | Masar Mohammad 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 | 2019-03-19 |
| Decision Date | 2019-10-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09420012449382 | K190713 | 000 |
| 09420012449481 | K190713 | 000 |
| 09420012448460 | K190713 | 000 |
| 09420012449191 | K190713 | 000 |
| 09420012448361 | K190713 | 000 |
| 09420012449498 | K190713 | 000 |