FDA 510(k) Applications for Medical Device Product Code "OMC"
(Reduced- Montage Standard Electroencephalograph)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K130013 | ADVANCED BRAIN MONITORING INC. | X4 SYSTEM | 01/31/2013 |
| K120447 | ADVANCED BRAIN MONITORING, INC. | X4 | 06/20/2012 |
| K152040 | ADVANCED BRAIN MONITORING, INC. | X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29) | 10/30/2015 |
| K192549 | Byteflies NV | Byteflies Kit | 06/22/2020 |
| K170363 | Ceribell, Inc. | Ceribell Pocket EEG Device | 05/08/2017 |
| K013863 | CLEVELAND MEDICAL DEVICES, INC. | CRYSTAL MONITOR MODEL 16 | 02/19/2002 |
| K970672 | CLEVELAND MEDICAL DEVICES, INC. | CRYSTAL-EEG MODEL 10 (MODEL 10) | 05/22/1997 |
| K001110 | CLEVELAND MEDICAL DEVICES, INC. | CRYSTAL-EEG MODEL 15 | 07/05/2000 |
| K060523 | CYBERKINETICS, INC. | NEUROPORT NEURAL SIGNAL PROCESSING SYSTEM | 03/28/2006 |
| K243185 | Epitel | REMI Remote EEG Monitoring System | 03/21/2025 |
| K203827 | Epitel, Inc. | REMI | 03/29/2021 |
| K230933 | Epitel, Inc. | REMI Remote EEG Monitoring System | 06/30/2023 |
| K242306 | Forest Devices, Inc. | SignalNED System (Model RE) | 09/04/2024 |
| K131944 | JORDAN NEUROSCIENCE, INC. | IEEG | 04/10/2014 |
| K024245 | MENNEN MEDICAL LTD. | ENVOY PATIENT MONITOR | 05/10/2004 |
| K242930 | Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) | Natus BrainWatch System | 11/19/2024 |
| K223628 | Neba Health, LLC | NEBA« Compact EEG2R Mobile Headset | 03/02/2023 |
| K110967 | NEURALYNX INC | ENTERPRISE ELECTROPHYSIOLOGY SYSTEM | 06/30/2011 |
| K221563 | Neurosteer Inc. | Neurosteer EEG Recorder | 10/24/2022 |
| K092477 | NEUROWAVE SYSTEMS, INC. | NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701 | 10/29/2010 |
| K183529 | Nihon Kohden Corporation | AE-120A EEG Head Set | 03/19/2019 |
| K020335 | OLYMPIC MEDICAL CORP. | OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330 | 06/18/2002 |
| K021485 | OXFORD BIOSIGNALS LIMITED | BIOSOMNIA | 09/11/2002 |
| K042309 | OXFORD BIOSIGNALS LIMITED | BIOSOMNIA-V3 | 09/08/2004 |
| K232779 | QX World Ltd | QUEX ED; QUEX S | 10/11/2024 |
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