| Device Type ID | 1615 |
| Device Name | Tympanometer |
| Regulation Description | Auditory Impedance Tester. |
| Regulation Medical Specialty | Ear Nose & Throat |
| 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 | 874.1090 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NAS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
|
| Device Type ID | 1615 |
| Device | Tympanometer |
| Product Code | NAS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Auditory Impedance Tester. |
| CFR Regulation Number | 874.1090 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AMPLIVOX LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AMPLIVOX, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |