Reduced- Montage Standard Electroencephalograph
FDA product code OMC · Class II (moderate risk) · 21 CFR 882.1400 · Neurology
Acquire, display, store, and archive electroencephalographic signals from the brain using a user-specified and/or sponsor-specified locations with a reduced array (i.e. less than < 16) of electrodes
29510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Cleveland Medical Devices, Inc. 3
- Epitel, Inc. 3
- Advanced Brain Monitoring, Inc. 3
- Ceribell, Inc. 2
- Forest Devices, Inc. 2
- Oxford Biosignals Limited 2
- Cyberkinetics, Inc. 1
- Neurowave Systems, Inc. 1
- Neuralynx, Inc. 1
- Mennen Medical, Inc. 1
- Jordan Neuroscience, Inc. 1
- Oxford Medilog, Inc. 1
- Nihon Kohden Corporation 1
- Byteflies NV 1
- Neurosteer, Inc. 1
- Neba Health, LLC 1
- Olympic Medical Corp. 1
- Qx World, Ltd. 1
- Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) 1
- Naox Technologies Sas 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261101 | Ceribell MonitorOMC · Traditional | Ceribell, Inc. | 06/30/2026SE |
| K251550 | NX01 (NX01)OMC · Traditional | Naox Technologies Sas | 11/25/2025SE |
| K251726 | SignalNED System (Model RE)OMC · Traditional | Forest Devices, Inc. | 09/03/2025SE |
| K243185 | REMI Remote EEG Monitoring SystemOMC · Traditional | Epitel | 03/21/2025SE |
| K242930 | Natus BrainWatch SystemOMC · Traditional | Natus Medical Incorporated Dba Excel-Tech Ltd.… | 11/19/2024SE |
| K232779 | Quex Ed; Quex SOMC · Traditional | Qx World, Ltd. | 10/11/2024SE |
| K242306 | SignalNED System (Model RE)OMC · Traditional | Forest Devices, Inc. | 09/04/2024SE |
| K230933 | REMI Remote EEG Monitoring SystemOMC · Traditional | Epitel, Inc. | 06/30/2023SE |
| K223628 | NEBA® Compact EEG2R Mobile HeadsetOMC · Traditional | Neba Health, LLC | 03/02/2023SE |
| K221563 | Neurosteer EEG RecorderOMC · Traditional | Neurosteer, Inc. | 10/24/2022SE |
| K203827 | RemiOMC · Traditional | Epitel, Inc. | 03/29/2021SE |
| K192549 | Byteflies KitOMC · Traditional | Byteflies NV | 06/22/2020SE |
| K183529 | AE-120A EEG Head SetOMC · Traditional | Nihon Kohden Corporation | 03/19/2019SE |
| K170363 | Ceribell Pocket EEG DeviceOMC · Traditional | Ceribell, Inc. | 05/08/2017SE |
| K152040 | X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System -…OMC · Traditional | Advanced Brain Monitoring, Inc. | 10/30/2015SE |
| K131944 | IeegOMC · Traditional | Jordan Neuroscience, Inc. | 04/10/2014SE |
| K130013 | X4 SystemOMC · Special | Advanced Brain Monitoring, Inc. | 01/31/2013SE |
| K120447 | X4OMC · Traditional | Advanced Brain Monitoring, Inc. | 06/20/2012SE |
| K110967 | Enterprise Electrophysiology SystemOMC · Traditional | Neuralynx, Inc. | 06/30/2011SE |
| K092477 | NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701OMC · Traditional | Neurowave Systems, Inc. | 10/29/2010SE |
| K060523 | Neuroport Neural Signal Processing SystemOMC · Special | Cyberkinetics, Inc. | 03/28/2006SE |
| K042309 | BIOSOMNIA-V3OMC · Traditional | Oxford Biosignals Limited | 09/08/2004SE |
| K024245 | Envoy Patient MonitorOMC · Traditional | Mennen Medical , Ltd. | 05/10/2004SE |
| K021485 | BiosomniaOMC · Traditional | Oxford Biosignals Limited | 09/11/2002SE |
| K020335 | Olympic Medical Lectromed Cerebral Function Monitor System, Model 5330OMC · Traditional | Olympic Medical Corp. | 06/18/2002SE |
| K013863 | Crystal Monitor Model 16OMC · Traditional | Cleveland Medical Devices, Inc. | 02/19/2002SE |
| K001110 | Crystal-Eeg Model 15OMC · Traditional | Cleveland Medical Devices, Inc. | 07/05/2000SE |
| K970672 | Crystal-Eeg Model 10 (Model 10)OMC · Traditional | Cleveland Medical Devices, Inc. | 05/22/1997SE |
| K781130 | Accessory to ECG Analysis Sys.OMC · Traditional | Oxford Medilog, Inc. | 08/23/1978SE |