The following data is part of a premarket notification filed by Fisher & Paykel Healthcare Ltd with the FDA for F&p Optiflow 3s Nasal Cannula (small, Medium, Large).
| Device ID | K191818 |
| 510k Number | K191818 |
| Device Name: | F&P Optiflow 3S Nasal Cannula (Small, Medium, Large) |
| 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 | 2019-07-05 |
| Decision Date | 2020-03-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09420012435422 | K191818 | 000 |
| 09420012435408 | K191818 | 000 |
| 09420012435378 | K191818 | 000 |
| 09420012466853 | K191818 | 000 |