The following data is part of a premarket notification filed by Fisher & Paykel Healthcare Ltd. with the FDA for F&p Brevida™ Nasal Pillows Mask.
| Device ID | K161412 |
| 510k Number | K161412 |
| Device Name: | F&P Brevida™ Nasal Pillows Mask |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | Fisher & Paykel Healthcare Ltd. 15 Maurice Paykel Place, East Tamaki Auckland, NZ 2013 |
| Contact | Amelia Ortiz |
| 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 | 2016-05-20 |
| Decision Date | 2017-01-18 |
| Summary: | summary |