The following data is part of a premarket notification filed by Fisher & Paykel Healthcare Ltd. with the FDA for F&p Optiflow Nasal Oxygen Cannula With Co2 Sampling.
| Device ID | K201723 |
| 510k Number | K201723 |
| Device Name: | F&P Optiflow Nasal Oxygen Cannula With CO2 Sampling |
| 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 | 2020-06-23 |
| Decision Date | 2021-03-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09420012471833 | K201723 | 000 |
| 09420012470959 | K201723 | 000 |
| 09420012470973 | K201723 | 000 |
| 09420012470997 | K201723 | 000 |
| 09420012471819 | K201723 | 000 |
| 09420012471611 | K201723 | 000 |
| 09420012471635 | K201723 | 000 |
| 09420012471659 | K201723 | 000 |
| 09420012471673 | K201723 | 000 |
| 09420012471697 | K201723 | 000 |
| 09420012471710 | K201723 | 000 |
| 09420012470935 | K201723 | 000 |