SMART-EP
Device Facts
| Record ID | K904926 |
|---|---|
| Device Name | SMART-EP |
| Applicant | Intelligent Hearing Systems |
| Product Code | GWJ · Neurology |
| Decision Date | Aug 2, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1900 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.
