QOW

Ventilatory Assistance Helmet

Product code: QOW
Device name: Ventilatory Assistance Helmet
Device class: Class N
Medical specialty: Unknown
Marketing pathway: EUA - Emergency Use Authorization

FDA classification definition

Patient interface for delivery of positive pressure to assist patient's breathing during declared public health emergency. Can be used with continuous and non-continuous ventilators, wall gas source, oxygen source, humidified gases.

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

Official FDA classification page: QOW

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