QOT

Emergency Ventilator

Product code: QOT
Device name: Emergency Ventilator
Device class: Class N
Medical specialty: Unknown
Marketing pathway: EUA - Emergency Use Authorization

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QOT

Classification and pathway per current FDA publications. Data from openFDA (CC0).