HMC · Monitor, Eye Movement, Diagnostic
Ophthalmic · 21 CFR 886.1510 · Class 2
Overview
| Product Code | HMC |
|---|---|
| Device Name | Monitor, Eye Movement, Diagnostic |
| Regulation | 21 CFR 886.1510 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
Identification
An eye movement monitor is an AC-powered device with an electrode intended to measure and record ocular movements.
Classification Rationale
Class II.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K931678 | ORTHOMET LHMC FEMORAL STEM | Orthomet, Inc. | Oct 14, 1994 | SESE |
Top Applicants
- Orthomet, Inc. — 1 clearance
