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) → OMC — Reduced- Montage Standard Electroencephalograph # OMC · Reduced- Montage Standard Electroencephalograph _Neurology · 21 CFR 882.1400 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMC ## Overview - **Product Code:** OMC - **Device Name:** Reduced- Montage Standard 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 (20 of 28) Showing 20 most recent of 28 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K251550](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMC/K251550.md) | NX01 (NX01) | Naox Technologies Sas | Nov 25, 2025 | SESE | | [K251726](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMC/K251726.md) | SignalNED System (Model RE) | Forest Devices, Inc. | Sep 3, 2025 | SESE | | [K243185](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMC/K243185.md) | REMI Remote EEG Monitoring System | Epitel | Mar 21, 2025 | SESE | | [K242930](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMC/K242930.md) | Natus BrainWatch System | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | Nov 19, 2024 | SESE | | [K232779](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMC/K232779.md) | QUEX ED; QUEX S | Qx World, Ltd. | Oct 11, 2024 | SESE | | [K242306](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMC/K242306.md) | SignalNED System (Model RE) | Forest Devices, Inc. | Sep 4, 2024 | SESE | | [K230933](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMC/K230933.md) | REMI Remote EEG Monitoring System | Epitel, Inc. | Jun 30, 2023 | SESE | | [K223628](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMC/K223628.md) | NEBA® Compact EEG2R Mobile Headset | Neba Health, LLC | Mar 2, 2023 | SESE | | [K221563](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMC/K221563.md) | Neurosteer EEG Recorder | Neurosteer, Inc. | Oct 24, 2022 | SESE | | [K203827](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMC/K203827.md) | REMI | Epitel, Inc. | Mar 29, 2021 | SESE | | [K192549](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMC/K192549.md) | Byteflies Kit | Byteflies NV | Jun 22, 2020 | SESE | | [K183529](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMC/K183529.md) | AE-120A EEG Head Set | Nihon Kohden Corporation | Mar 19, 2019 | SESE | | [K170363](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMC/K170363.md) | Ceribell Pocket EEG Device | Ceribell, Inc. | May 8, 2017 | SESE | | [K152040](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMC/K152040.md) | X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29) | Advanced Brain Monitoring, Inc. | Oct 30, 2015 | SESE | | [K131944](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMC/K131944.md) | IEEG | Jordan Neuroscience, Inc. | Apr 10, 2014 | SESE | | [K130013](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMC/K130013.md) | X4 SYSTEM | Advanced Brain Monitoring, Inc. | Jan 31, 2013 | SESE | | [K120447](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMC/K120447.md) | X4 | Advanced Brain Monitoring, Inc. | Jun 20, 2012 | SESE | | [K110967](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMC/K110967.md) | ENTERPRISE ELECTROPHYSIOLOGY SYSTEM | Neuralynx, Inc. | Jun 30, 2011 | SESE | | [K092477](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMC/K092477.md) | NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701 | Neurowave Systems, Inc. | Oct 29, 2010 | SESE | | [K060523](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMC/K060523.md) | NEUROPORT NEURAL SIGNAL PROCESSING SYSTEM | Cyberkinetics, Inc. | Mar 28, 2006 | SESE | ## Top Applicants - Advanced Brain Monitoring, Inc. — 3 clearances - Cleveland Medical Devices, Inc. — 3 clearances - Epitel, Inc. — 2 clearances - Forest Devices, Inc. — 2 clearances - Oxford Biosignals Limited — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMC](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMC) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com