NQY

Ventilator, Continuous, Minimal Ventilatory Support, Home Use

Product code
NQY
Device name
Ventilator, Continuous, Minimal Ventilatory Support, Home Use
Device class
Class 2
21 CFR
21 CFR 868.5895
Medical specialty
Anesthesiology
Marketing pathway
510(K)
Flag
Life-sustaining / life-supporting

FDA classification definition

This continuous ventilator, which operates using a fixed or passive exhaust port, is intended to treat patients with respiratory failure in the home.

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

Official FDA classification page: NQY
Classification and pathway per current FDA publications. Data from openFDA (CC0).