QBY — Positive Airway Pressure System Class II
FDA product code QBY covers "Positive Airway Pressure System", a Class II medical device regulated under 21 CFR 868.5273. Submissions are reviewed by the Anesthesiology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QBY
- Device Class
- Class II
- Regulation Number
- 868.5273
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
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.