| Device Type ID | 1466 |
| Device Name | Calibrator, Hearing Aid / Earphone And Analysis Systems |
| Regulation Description | Hearing Aid Calibrator And Analysis System. |
| 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) Exempt |
| CFR Regulation Number | 874.3310 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ETW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |