← Product Code [HLL](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLL) · K872111

# ORTHOTONE (K872111)

_Orthotone Corp. · HLL · Nov 16, 1988 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLL/K872111

## Device Facts

- **Applicant:** Orthotone Corp.
- **Product Code:** [HLL](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLL.md)
- **Decision Date:** Nov 16, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.1510
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Regulatory Identification

An eye movement monitor is an AC-powered device with an electrode intended to measure and record ocular movements.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLL/K872111](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLL/K872111)

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