| Device Type ID | 3641 |
| Device Name | Stimulator, Auditory, Evoked Response |
| Regulation Description | Evoked Response Auditory Stimulator. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.1900 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GWJ |
| 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 | 3641 |
| Device | Stimulator, Auditory, Evoked Response |
| Product Code | GWJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Evoked Response Auditory Stimulator. |
| CFR Regulation Number | 882.1900 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CAREFUSION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GN OTOMETRICS A/S | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
INTELLIGENT HEARING SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INTERACOUSTICS A/S | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WILLIAM DEMANT HOLDING A/S | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Slipped | 53 |
Extrusion | 50 |
Use Of Device Problem | 4 |
Device Issue | 4 |
False Positive Result | 3 |
Difficult To Remove | 2 |
Sticking | 2 |
Physical Resistance / Sticking | 2 |
False Negative Result | 1 |
Split | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Fire | 1 |
Battery | 1 |
Device Tipped Over | 1 |
Signal Artifact | 1 |
Explosion | 1 |
| Total Device Problems | 128 |