The following data is part of a premarket notification filed by Fisher & Paykel Healthcare Limited with the FDA for Airvo Nebulizer Adapter.
| Device ID | K211560 |
| 510k Number | K211560 |
| Device Name: | Airvo Nebulizer Adapter |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place, East Tamaki Auckland, NZ 2013 |
| Contact | Reena Daken |
| Correspondent | Reena Daken Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place, East Tamaki Auckland, NZ 2013 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-20 |
| Decision Date | 2021-12-10 |