ENGPLUS
Device Facts
| Record ID | K010059 |
|---|---|
| Device Name | ENGPLUS |
| Applicant | Western Systems Research, Inc. |
| Product Code | GWN · Neurology |
| Decision Date | Feb 27, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1460 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.