MODEL 8400 W/MODIFICATIONS (SPECTRUM 32)
Device Facts
| Record ID | K860801 |
|---|---|
| Device Name | MODEL 8400 W/MODIFICATIONS (SPECTRUM 32) |
| Applicant | Cadwell Laboratories, Inc. |
| Product Code | GWE · Neurology |
| Decision Date | Nov 18, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1890 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An evoked response photic stimulator is a device used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye for use in evoked response measurements or for electroencephalogram (EEG) activation.
