Panels › Anesthesiology › Product code QAV · Class 2
High Flow/High Velocity Humidified Oxygen Delivery Device
Regulation 868.5454
0510(k)s in 12 months (3 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in QAV
| Company | 510(k)s | Recalls |
|---|---|---|
| Fisher & Paykel Healthcare | 1 | 1 |
| Vapotherm, Inc. | 2 | 0 |
| 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 | K221338 |
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