FDA.reportPublic FDA data

Product code QBY

Device name
Positive Airway Pressure System
Medical specialty
Anesthesiology
Device class
2
Regulation number
868.5273
Review panel
AN
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.
Source
FDA openFDA device classification dataset