High Flow/High Velocity Humidified Oxygen Delivery Device
The High Flow/High Velocity Humidified Oxygen Delivery Device is an anesthesiology device intended to deliver high flow and/or high velocity oxygen with humidification to patients, used in respiratory support settings such as the ICU or during procedural sedation. It is classified as a Class 2 device under regulation 868.5454, requiring 510(k) premarket notification, and falls within the Anesthesiology (AN) medical specialty. The product code is QAV. It is not an implant and is not life-sustaining.
Basic Information
- Product Code
- QAV
- Device Class
- FDA class 2
- Regulation Number
- 868.5454
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
Definition
Intended to deliver high flow and/or high velocity oxygen with humidification.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.