QBY · Class II · 21 CFR 868.5273

FDA Product Code QBY: Positive Airway Pressure System

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.

Leading manufacturers include Fresca Medical and Fresca Medical, Inc..

2
Total
1
Cleared
139d
Avg days
2018
Since

FDA 510(k) Cleared Positive Airway Pressure System Devices (Product Code QBY)

2 devices
1–2 of 2
Cleared Jun 29, 2020
Somnera System
K200698
Fresca Medical, Inc.
Anesthesiology · 104d
Not Cleared Jun 05, 2018
Curve Positive Airway Pressure System
DEN170089
Fresca Medical
Anesthesiology · 173d

About Product Code QBY - Regulatory Context