Product code QOW

Device name

Ventilatory Assistance Helmet

Medical specialty

Unknown

Device class

N

Review panel

AN

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset