Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1400](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1400) → OMA — Amplitude-Integrated Electroencephalograph

# OMA · Amplitude-Integrated Electroencephalograph

_Neurology · 21 CFR 882.1400 · Class 2_

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

## Overview

- **Product Code:** OMA
- **Device Name:** Amplitude-Integrated Electroencephalograph
- **Regulation:** [21 CFR 882.1400](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1400)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)
- **3rd-party reviewable:** yes

## 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.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (16 of 16)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K192889](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMA/K192889.md) | Neo | Eemagine Medical Imaging Solutions GmbH | Jan 30, 2020 | SESE |
| [K163644](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMA/K163644.md) | Nihon Kohden QP-160AK EEG Trend Program | Nihon Kohden Corporation | May 19, 2017 | SESE |
| [K161027](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMA/K161027.md) | Cadwell AmpliScan | Cadwell Industries, Inc. | Nov 8, 2016 | SESE |
| [K152301](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMA/K152301.md) | Background Pattern Classification [BPc(TM)] | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | Jun 3, 2016 | SESE |
| [K130238](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMA/K130238.md) | NIHON KOHDEN AE-918P NEURO UNIT | Nihon Kohden Corp. | Mar 4, 2015 | SESE |
| [K131789](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMA/K131789.md) | CEREBRALOGIK- AEEG | Mennen Medical , Ltd. | Dec 27, 2013 | SESE |
| [K123079](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMA/K123079.md) | OLYMPIC BRAINZ MONITOR | Excel-Tech Ltd. (Xltek) | May 8, 2013 | SESE |
| [K120485](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMA/K120485.md) | NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P | Nihon Kohden America, Inc. | Mar 16, 2012 | SESE |
| [K092573](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMA/K092573.md) | NIHON KOHDEN QP-160AK EEG TREND PROGRAM | Nihon Kohden America, Inc. | Jul 9, 2010 | SESE |
| [K093949](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMA/K093949.md) | OLYMPIC BRAINZ MONITOR MODEL OBM70001 | Natus Medical, Inc. | Jun 16, 2010 | SESE |
| [K081551](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMA/K081551.md) | TWIN NEUROTRAC-III | Astro-Med, Inc. | Dec 24, 2008 | SESE |
| [K080217](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMA/K080217.md) | COMPONENT NEUROMONITORING SYSTEM | Moberg Research, Inc. | Nov 5, 2008 | SESE |
| [K071449](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMA/K071449.md) | BRM3 BRAIN MONITOR | Brainz Instruments , Ltd. | Sep 14, 2007 | SESE |
| [K031149](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMA/K031149.md) | OLYMPIC CFM 6000 | Olympic Medical Corp. | May 14, 2003 | SESE |
| [K983229](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMA/K983229.md) | OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM | Olympic Medical Corp. | Mar 23, 1999 | SESE |
| [K791580](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMA/K791580.md) | CEREBRAL FUNCTION MONITOR 870 | Applied Medical Research | Sep 4, 1979 | SESE |

## Top Applicants

- Nihon Kohden America, Inc. — 2 clearances
- Olympic Medical Corp. — 2 clearances
- Applied Medical Research — 1 clearance
- Astro-Med, Inc. — 1 clearance
- Brainz Instruments , Ltd. — 1 clearance

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

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