Product code NQY
- Device name
- Ventilator, Continuous, Minimal Ventilatory Support, Home Use
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5895
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- This continuous ventilator, which operates using a fixed or passive exhaust port, is intended to treat patients with respiratory failure in the home.
- Source
- FDA openFDA device classification dataset