NQY
- Product code
- NQY
- Device name
- Ventilator, Continuous, Minimal Ventilatory Support, Home Use
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.5895
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- Flag
- Life-sustaining / life-supporting
FDA classification definition
This continuous ventilator, which operates using a fixed or passive exhaust port, is intended to treat patients with respiratory failure in the home.
Official FDA classification page: NQY
Classification and pathway per current FDA publications. Data from openFDA (CC0).