SMART-SCREENER (AUDITORY)
Device Facts
| Record ID | K925648 |
|---|---|
| Device Name | SMART-SCREENER (AUDITORY) |
| Applicant | Intelligent Hearing Systems |
| Product Code | GWJ · Neurology |
| Decision Date | May 11, 1993 |
| 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.
