510(k) K221338 ยท QAV High Flow/High Velocity Humidified Oxygen Delivery Device
F&P Airvo 3
| Applicant | Fisher & Paykel Healthcare, Manukau, NZ |
| Decision | Substantially Equivalent, Jan 27, 2023 |
| Received | May 9, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221338
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2024 | Fisher & Paykel Healthcare, Ltd. PT301US Airvo 3 Respiratory Support Device
with software version 1.2.0 and/or 1.5.1
The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontane Open, Classified |
QAV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.