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Positive Airway Pressure System

FDA product code QBY · 1 cleared devices

Class 2 Anesthesiology
Regulation
21 CFR 868.5273
Review panel
AN
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2020-06-29 – 2020-06-29

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.

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