| Device Type ID | 1428 |
| Device Name | Pillow, Cervical (for Mild Sleep Apnea) |
| Regulation Description | Intraoral Devices For Snoring And Intraoral Devices For Snoring And Obstructive Sleep Apnea. |
| Regulation Medical Specialty | Dental |
| Review Panel | Ear Nose & Throat |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Ear, Nose, And Throat Devices Branch (ENTB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 872.5570 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MYB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1428 |
| Device | Pillow, Cervical (for Mild Sleep Apnea) |
| Product Code | MYB |
| 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 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ADVANCED BRAIN MONITORING, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |