Reduced- Montage Standard Electroencephalograph
Regulation 882.1400
2510(k)s in 12 months (29 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OMC
| Company | 510(k)s | Recalls |
|---|---|---|
| Advanced Brain Monitoring, Inc. | 3 | 0 |
| Cleveland Medical Devices, Inc. | 3 | 0 |
| Epitel | 3 | 0 |
| Ceribell, Inc. | 2 | 0 |
| Forest Devices, Inc. | 2 | 0 |
| Oxford Biosignals Limited | 2 | 0 |
| Byteflies NV | 1 | 0 |
| Cyberkinetics, Inc. | 1 | 0 |
| Jordan Neuroscience, Inc. | 1 | 0 |
| Mennen Medical , Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 30, 2026 | K261101 | Ceribell Monitor Ceribell, Inc. | OMC |
| Nov 25, 2025 | K251550 | NX01 (NX01) Naox Technologies Sas, FR | OMC |
| Sep 3, 2025 | K251726 | SignalNED System (Model RE) Forest Devices, Inc. | OMC |
| Mar 21, 2025 | K243185 | REMI Remote EEG Monitoring System Epitel | OMC |
| Nov 19, 2024 | K242930 | Natus BrainWatch System Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), CA | OMC |
| Oct 11, 2024 | K232779 | QUEX ED; QUEX S Qx World, Ltd., HU | OMC |
| Sep 4, 2024 | K242306 | SignalNED System (Model RE) Forest Devices, Inc. | OMC |
| Jun 30, 2023 | K230933 | REMI Remote EEG Monitoring System Epitel, Inc. | OMC |
| Mar 2, 2023 | K223628 | NEBA® Compact EEG2R Mobile Headset Neba Health, LLC | OMC |
| Oct 24, 2022 | K221563 | Neurosteer EEG Recorder Neurosteer, Inc. | OMC |
| Mar 29, 2021 | K203827 | REMI Epitel, Inc. | OMC |
| Jun 22, 2020 | K192549 | Byteflies Kit Byteflies NV, BE | OMC |
| Mar 19, 2019 | K183529 | AE-120A EEG Head Set Nihon Kohden Corporation, JP | OMC |
| May 8, 2017 | K170363 | Ceribell Pocket EEG Device Ceribell, Inc. | OMC |
| Oct 30, 2015 | K152040 | X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29) Advanced Brain Monitoring, Inc. | OMC |
| Apr 10, 2014 | K131944 | IEEG Jordan Neuroscience, Inc. | OMC |
| Jan 31, 2013 | K130013 | X4 SYSTEM Advanced Brain Monitoring, Inc. | OMC |
| Jun 20, 2012 | K120447 | X4 Advanced Brain Monitoring, Inc. | OMC |
| Jun 30, 2011 | K110967 | ENTERPRISE ELECTROPHYSIOLOGY SYSTEM Neuralynx, Inc. | OMC |
| Oct 29, 2010 | K092477 | NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701 Neurowave Systems, Inc. | OMC |
| Mar 28, 2006 | K060523 | NEUROPORT NEURAL SIGNAL PROCESSING SYSTEM Cyberkinetics, Inc. | OMC |
| Sep 8, 2004 | K042309 | BIOSOMNIA-V3 Oxford Biosignals Limited | OMC |
| May 10, 2004 | K024245 | ENVOY PATIENT MONITOR Mennen Medical , Ltd., IL | OMC |
| Sep 11, 2002 | K021485 | BIOSOMNIA Oxford Biosignals Limited | OMC |
| Jun 18, 2002 | K020335 | OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330 Olympic Medical Corp. | OMC |
| Feb 19, 2002 | K013863 | CRYSTAL MONITOR MODEL 16 Cleveland Medical Devices, Inc. | OMC |
| Jul 5, 2000 | K001110 | CRYSTAL-EEG MODEL 15 Cleveland Medical Devices, Inc. | OMC |
| May 22, 1997 | K970672 | CRYSTAL-EEG MODEL 10 (MODEL 10) Cleveland Medical Devices, Inc. | OMC |
| Aug 23, 1978 | K781130 | ACCESSORY TO ECG ANALYSIS SYS. Oxford Medilog, Inc. | OMC |
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