FDA Product Code
FDA Product Code OMC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1400
510(k) Clearances — 29 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261101 | Ceribell Monitor | Ceribell, Inc. | 2026-06-30 | Traditional | PDF ↗ |
| K251550 | NX01 (NX01) | Naox Technologies Sas | 2025-11-25 | Traditional | PDF ↗ |
| K251726 | SignalNED System (Model RE) | Forest Devices, Inc. | 2025-09-03 | Traditional | PDF ↗ |
| K243185 | REMI Remote EEG Monitoring System | Epitel | 2025-03-21 | Traditional | PDF ↗ |
| K242930 | Natus BrainWatch System | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2024-11-19 | Traditional | PDF ↗ |
| K232779 | QUEX ED; QUEX S | Qx World, Ltd. | 2024-10-11 | Traditional | PDF ↗ |
| K242306 | SignalNED System (Model RE) | Forest Devices, Inc. | 2024-09-04 | Traditional | PDF ↗ |
| K230933 | REMI Remote EEG Monitoring System | Epitel, Inc. | 2023-06-30 | Traditional | PDF ↗ |
| K223628 | NEBA® Compact EEG2R Mobile Headset | Neba Health, LLC | 2023-03-02 | Traditional | PDF ↗ |
| K221563 | Neurosteer EEG Recorder | Neurosteer, Inc. | 2022-10-24 | Traditional | PDF ↗ |
| K203827 | REMI | Epitel, Inc. | 2021-03-29 | Traditional | PDF ↗ |
| K192549 | Byteflies Kit | Byteflies NV | 2020-06-22 | Traditional | PDF ↗ |
| K183529 | AE-120A EEG Head Set | Nihon Kohden Corporation | 2019-03-19 | Traditional | PDF ↗ |
| K170363 | Ceribell Pocket EEG Device | Ceribell, Inc. | 2017-05-08 | Traditional | PDF ↗ |
| K152040 | X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29) | Advanced Brain Monitoring, Inc. | 2015-10-30 | Traditional | PDF ↗ |
| K131944 | IEEG | Jordan Neuroscience, Inc. | 2014-04-10 | Traditional | PDF ↗ |
| K130013 | X4 SYSTEM | Advanced Brain Monitoring, Inc. | 2013-01-31 | Special | PDF ↗ |
| K120447 | X4 | Advanced Brain Monitoring, Inc. | 2012-06-20 | Traditional | PDF ↗ |
| K110967 | ENTERPRISE ELECTROPHYSIOLOGY SYSTEM | Neuralynx, Inc. | 2011-06-30 | Traditional | PDF ↗ |
| K092477 | NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701 | Neurowave Systems, Inc. | 2010-10-29 | Traditional | PDF ↗ |
| K060523 | NEUROPORT NEURAL SIGNAL PROCESSING SYSTEM | Cyberkinetics, Inc. | 2006-03-28 | Special | PDF ↗ |
| K042309 | BIOSOMNIA-V3 | Oxford Biosignals Limited | 2004-09-08 | Traditional | PDF ↗ |
| K024245 | ENVOY PATIENT MONITOR | Mennen Medical , Ltd. | 2004-05-10 | Traditional | PDF ↗ |
| K021485 | BIOSOMNIA | Oxford Biosignals Limited | 2002-09-11 | Traditional | PDF ↗ |
| K020335 | OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330 | Olympic Medical Corp. | 2002-06-18 | Traditional | PDF ↗ |
| K013863 | CRYSTAL MONITOR MODEL 16 | Cleveland Medical Devices, Inc. | 2002-02-19 | Traditional | PDF ↗ |
| K001110 | CRYSTAL-EEG MODEL 15 | Cleveland Medical Devices, Inc. | 2000-07-05 | Traditional | PDF ↗ |
| K970672 | CRYSTAL-EEG MODEL 10 (MODEL 10) | Cleveland Medical Devices, Inc. | 1997-05-22 | Traditional | PDF ↗ |
| K781130 | ACCESSORY TO ECG ANALYSIS SYS. | Oxford Medilog, Inc. | 1978-08-23 | Traditional | PDF ↗ |
Product code OMC · Class II · Neurology. Data: openFDA.