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 (last 3 years): 2

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).

Official FDA classification page: QBY

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