EVOKED 3500 POTENTIAL SYSTEM
Device Facts
| Record ID | K832084 |
|---|---|
| Device Name | EVOKED 3500 POTENTIAL SYSTEM |
| Applicant | Tracor Northern, Inc. |
| Product Code | GWE · Neurology |
| Decision Date | Aug 16, 1983 |
| 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.
