The following data is part of a premarket notification filed by Fisher &paykel Healthcare Ltd. with the FDA for Optiflow Oxygen Kit.
| Device ID | K211096 |
| 510k Number | K211096 |
| Device Name: | Optiflow Oxygen 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 | 2021-04-13 |
| Decision Date | 2022-01-28 |