Noninvasive Positive Airway Pressure System, Facility Use
Medical specialty
Anesthesiology
Device class
2
Regulation number
868.5895
Review panel
AN
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
To mechanically assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas through noninvasive continuous positive airway pressure.