WAVE GATE
Device Facts
| Record ID | K853412 |
|---|---|
| Device Name | WAVE GATE |
| Applicant | Wolfline Corp. |
| Product Code | GWE · Neurology |
| Decision Date | Oct 28, 1985 |
| 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.