Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1510](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1510) → HMC — Monitor, Eye Movement, Diagnostic

# HMC · Monitor, Eye Movement, Diagnostic

_Ophthalmic · 21 CFR 886.1510 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HMC

## Overview

- **Product Code:** HMC
- **Device Name:** Monitor, Eye Movement, Diagnostic
- **Regulation:** [21 CFR 886.1510](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1510)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **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](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HMC/K931678.md) | ORTHOMET LHMC FEMORAL STEM | Orthomet, Inc. | Oct 14, 1994 | SESE |

## Top Applicants

- Orthomet, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HMC](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HMC)

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