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 Durin
| Device Type ID | 205 |
| Device Name | Positive Airway Pressure System |
| Physical State | Mask And Flow Generator |
| Technical Method | Use Of A Mask And A Flow Generator By A Patient While Sleeping. |
| Target Area | Nasopharynx |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Respiratory Devices Branch (RPDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 868.5273 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QBY |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 205 |
| Device | Positive Airway Pressure System |
| Product Code | QBY |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 868.5273 [🔎] |