QOT — Emergency Ventilator Class N
FDA product code QOT covers "Emergency Ventilator", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QOT
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Unknown
- Implant
- No
Definition
A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas during emergency and/or transfer use. Device is intended to be used temporarily and/or in emergency situations during declared public health emergency.