| Device Type ID | 1661 |
| Device Name | Device, Inflation, Middle Ear |
| 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) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | MJV |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1661 |
| Device | Device, Inflation, Middle Ear |
| Product Code | MJV |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 1 |