NQY — Ventilator, Continuous, Minimal Ventilatory Support, Home Use Class II
FDA product code NQY covers "Ventilator, Continuous, Minimal Ventilatory Support, Home Use", a Class II medical device regulated under 21 CFR 868.5895. Submissions are reviewed by the Anesthesiology panel.
Classification Details
- Product Code
- NQY
- Device Class
- Class II
- Regulation Number
- 868.5895
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Definition
This continuous ventilator, which operates using a fixed or passive exhaust port, is intended to treat patients with respiratory failure in the home.