← FDA Medical Device Classifications
Continuous, Ventilator, Home Use
NOU · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.5895
Classification
- FDA Product Code
NOU- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 868.5895
- Review panel
- AN
- Medical specialty
- Anesthesiology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- Y
- Implant
- N
- Third-party review
- N
Definition
This product code was needed for the home use indication. CBK is not a tracked device and NOU is a tracked device.
Market data
- Cleared 510(k) submissions
- 7
- Registered establishments
- 30
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown