← FDA Medical Device Classifications
High Flow/High Velocity Humidified Oxygen Delivery Device
QAV · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.5454
Classification
- FDA Product Code
QAV- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 868.5454
- Review panel
- AN
- Medical specialty
- Anesthesiology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Intended to deliver high flow and/or high velocity oxygen with humidification.
Market data
- Cleared 510(k) submissions
- 3
- Registered establishments
- 6
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown