← Product Code [OMC](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMC) · K001110

# CRYSTAL-EEG MODEL 15 (K001110)

_Cleveland Medical Devices, Inc. · OMC · Jul 5, 2000 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMC/K001110

## Device Facts

- **Applicant:** Cleveland Medical Devices, Inc.
- **Product Code:** [OMC](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMC.md)
- **Decision Date:** Jul 5, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.1400
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMC/K001110](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMC/K001110)

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