QBYClass II
Positive Airway Pressure System
Anesthesiology · 21 CFR 868.5273
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.
MDR events2All time
Recalls0All time
Registered firms1Currently listed
510(k) clearances2All time
Recent MDR events
2 adverse event reports on file
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
1 firms currently registered for this product code
510(k) clearances
2 clearances for this product code