Positive Airway Pressure System
The Positive Airway Pressure System is a prescription noninvasive ventilatory device that delivers expiratory positive airway pressure for patients with obstructive sleep apnea, and also provides positive airway pressure during incipient apnea. The system may include a dedicated flow generator and a patient interface. It is classified as FDA Class 2, meaning it requires a 510(k) premarket notification to demonstrate substantial equivalence to a legally marketed predicate device. The product code is QBY under regulation 868.5273 in the Anesthesiology specialty. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QBY
- Device Class
- FDA class 2
- Regulation Number
- 868.5273
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.