QBY

Positive Airway Pressure System

Product code

QBY

Device name

Positive Airway Pressure System

Device class

Class 2

21 CFR

21 CFR 868.5273

Medical specialty

Anesthesiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification definition

A positive airway pressure delivery system is a prescription noninvasive ventilatory device that delivers expiratory positive airway pressure for patients suffering from obstructive sleep apnea. The system also provides positive airway pressure during incipient apnea. The system may include a dedicated flow generator and a patient interface.

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