510(k) K221338
K221338 is an FDA 510(k) premarket notification submitted by Fisher & Paykel Healthcare for the device "F&P Airvo 3". The FDA issued a decision of Substantially Equivalent on January 27, 2023. The device falls under product code QAV (High Flow/High Velocity Humidified Oxygen Delivery Device), a Class II device regulated under 21 CFR 868.5454. Fisher & Paykel Healthcare has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 27, 2023
- Date Received
- May 9, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- High Flow/High Velocity Humidified Oxygen Delivery Device
- Device Class
- Class II
- Regulation Number
- 868.5454
- Review Panel
- AN
- Submission Type
Intended to deliver high flow and/or high velocity oxygen with humidification.