The following data is part of a premarket notification filed by Fisher & Paykel Healthcare Ltd with the FDA for F&p 850 Airspiral Adult Niv And Nhf Circuit Kit.
| Device ID | K212031 |
| 510k Number | K212031 |
| Device Name: | F&P 850 AirSpiral Adult NIV And NHF Circuit Kit |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| 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 | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-29 |
| Decision Date | 2022-04-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09420012469014 | K212031 | 000 |