QOR — Continuous Ventilator, Minimal Ventilatory Support Class N
FDA product code QOR covers "Continuous Ventilator, Minimal Ventilatory Support", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QOR
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Unknown
- Implant
- No
Definition
A continuous ventilator (respirator) for emergency use that is intended to provide minimal ventilatory support to mechanically control or assist patient breathing during declared public health emergency.