QOU

Emergency Resuscitator

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

FDA classification definition

Emergency ventilator incorporating bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway (may be automated) for use during declared public health emergency.

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

Official FDA classification page: QOU

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