F&P Airvo 3
FDA 510(k) clearance K221338 · decided 2023-01-27
Clearance details
- K-number
- K221338
- Device name
- F&P Airvo 3
- Applicant
- Fisher & Paykel Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2022-05-09
- Decision date
- 2023-01-27
- Days to decision
- 263 days
- Clearance type
- Traditional
- Product code
- QAV
- Device class
- 2
- Regulation number
- 868.5454
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Manukau, NZ
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Ai recall (Z-3262-2024) | Fisher & Paykel Healthcare, Ltd. | 2024-09-25 |