OMC · Reduced- Montage Standard Electroencephalograph
Neurology · 21 CFR 882.1400 · Class 2
Overview
| Product Code | OMC |
|---|---|
| Device Name | Reduced- Montage Standard Electroencephalograph |
| Regulation | 21 CFR 882.1400 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 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 | NX01 (NX01) | Naox Technologies Sas | Nov 25, 2025 | SESE |
| K251726 | SignalNED System (Model RE) | Forest Devices, Inc. | Sep 3, 2025 | SESE |
| K243185 | REMI Remote EEG Monitoring System | Epitel | Mar 21, 2025 | SESE |
| K242930 | Natus BrainWatch System | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | Nov 19, 2024 | SESE |
| K232779 | QUEX ED; QUEX S | Qx World, Ltd. | Oct 11, 2024 | SESE |
| K242306 | SignalNED System (Model RE) | Forest Devices, Inc. | Sep 4, 2024 | SESE |
| K230933 | REMI Remote EEG Monitoring System | Epitel, Inc. | Jun 30, 2023 | SESE |
| K223628 | NEBA® Compact EEG2R Mobile Headset | Neba Health, LLC | Mar 2, 2023 | SESE |
| K221563 | Neurosteer EEG Recorder | Neurosteer, Inc. | Oct 24, 2022 | SESE |
| K203827 | REMI | Epitel, Inc. | Mar 29, 2021 | SESE |
| K192549 | Byteflies Kit | Byteflies NV | Jun 22, 2020 | SESE |
| K183529 | AE-120A EEG Head Set | Nihon Kohden Corporation | Mar 19, 2019 | SESE |
| K170363 | Ceribell Pocket EEG Device | Ceribell, Inc. | May 8, 2017 | SESE |
| K152040 | 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 | IEEG | Jordan Neuroscience, Inc. | Apr 10, 2014 | SESE |
| K130013 | X4 SYSTEM | Advanced Brain Monitoring, Inc. | Jan 31, 2013 | SESE |
| K120447 | X4 | Advanced Brain Monitoring, Inc. | Jun 20, 2012 | SESE |
| K110967 | ENTERPRISE ELECTROPHYSIOLOGY SYSTEM | Neuralynx, Inc. | Jun 30, 2011 | SESE |
| K092477 | NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701 | Neurowave Systems, Inc. | Oct 29, 2010 | SESE |
| K060523 | 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
