Definition: Intranasal Device That Creates Expiratory Resistance For The Treatment Of Obstructive Sleep Apnea.
| Device Type ID | 1374 |
| Device Name | Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea |
| Physical State | Plastic With Adhesive; Valve That Changes Position With Inspiration/expiration To Provide Decreased/increased Resistance |
| Technical Method | Intranasal Device That Creates Expiratory Resistance |
| Target Area | Inserted Into Nares Of Nose To Maintain Upper Airway Pressure. |
| Regulation Description | Intraoral Devices For Snoring And Intraoral Devices For Snoring And Obstructive Sleep Apnea. |
| Regulation Medical Specialty | Dental |
| Review Panel | Dental |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Dental Devices Branch (DEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 872.5570 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OHP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1374 |
| Device | Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea |
| Product Code | OHP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Intraoral Devices For Snoring And Intraoral Devices For Snoring And Obstructive Sleep Apnea. |
| CFR Regulation Number | 872.5570 [🔎] |