The following data is part of a premarket notification filed by Fisher And Paykel Healthcare Limited with the FDA for F&p Nivairotm Rt046 Non-vented Hospital Full Face Mask, Standard Elbow Version.
| Device ID | K173060 |
| 510k Number | K173060 |
| Device Name: | F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | Fisher And Paykel Healthcare Limited 15 Maurice Paykel Place Auckland, NZ 2013 |
| Contact | Ashley Nguyen |
| Correspondent | Ashley Nguyen Fisher And Paykel Healthcare Limited 15 Maurice Paykel Place 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 | 2017-09-28 |
| Decision Date | 2018-01-25 |
| Summary: | summary |