NOU

Continuous, Ventilator, Home Use

Product code

NOU

Device name

Continuous, Ventilator, Home Use

Device class

Class 2

21 CFR

21 CFR 868.5895

Medical specialty

Anesthesiology

Marketing pathway

510(K)

Flag

Life-sustaining / life-supporting

510(k) clearances (last 3 years)

7

FDA classification definition

This product code was needed for the home use indication. CBK is not a tracked device and NOU is a tracked device.

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

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-01-13.