ORTHOTONE
Device Facts
| Record ID | K872111 |
|---|---|
| Device Name | ORTHOTONE |
| Applicant | Orthotone Corp. |
| Product Code | HLL · Ophthalmic |
| Decision Date | Nov 16, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1510 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An eye movement monitor is an AC-powered device with an electrode intended to measure and record ocular movements.
