QBY
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Positive Airway Pressure System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5273
- Medical specialty
- Anesthesiology
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| Somnera System (K200698) | Fresca Medical, Inc. | 2020-06-29 |
| Curve Positive Airway Pressure System (DEN170089) | Fresca Medical | 2018-06-05 |
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