QAV — High Flow/High Velocity Humidified Oxygen Delivery Device Class II
FDA product code QAV covers "High Flow/High Velocity Humidified Oxygen Delivery Device", a Class II medical device regulated under 21 CFR 868.5454. Submissions are reviewed by the Anesthesiology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QAV
- Device Class
- Class II
- Regulation Number
- 868.5454
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Definition
Intended to deliver high flow and/or high velocity oxygen with humidification.