← FDA Medical Device Classifications
Ventilator, Continuous, Minimal Ventilatory Support, Home Use
NQY · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.5895
Classification
- FDA Product Code
NQY- 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 continuous ventilator, which operates using a fixed or passive exhaust port, is intended to treat patients with respiratory failure in the home.
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 0
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown