EYETECT TREMOR MONITOR UNIT (TMU)
Device Facts
| Record ID | K003644 |
|---|---|
| Device Name | EYETECT TREMOR MONITOR UNIT (TMU) |
| Applicant | Eyetect, LLC |
| Product Code | GWN · Neurology |
| Decision Date | Feb 1, 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.