OMC — Reduced- Montage Standard Electroencephalograph Class II
Classification Details
- Product Code
- OMC
- Device Class
- Class II
- Regulation Number
- 882.1400
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Definition
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
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251550 | naox technologies | NX01 (NX01) | November 25, 2025 |
| K251726 | forest devices | SignalNED System (Model RE) | September 3, 2025 |
| K243185 | epitel | REMI Remote EEG Monitoring System | March 21, 2025 |
| K242930 | natus medical incorporated dba excel-tech ltd. (xltek) | Natus BrainWatch System | November 19, 2024 |
| K232779 | qx world | QUEX ED; QUEX S | October 11, 2024 |
| K242306 | forest devices | SignalNED System (Model RE) | September 4, 2024 |
| K230933 | epitel | REMI Remote EEG Monitoring System | June 30, 2023 |
| K223628 | neba health | NEBA® Compact EEG2R Mobile Headset | March 2, 2023 |
| K221563 | neurosteer | Neurosteer EEG Recorder | October 24, 2022 |
| K203827 | epitel | REMI | March 29, 2021 |
| K192549 | byteflies | Byteflies Kit | June 22, 2020 |
| K183529 | nihon kohden corporation | AE-120A EEG Head Set | March 19, 2019 |
| K170363 | ceribell | Ceribell Pocket EEG Device | May 8, 2017 |
| K152040 | advanced brain monitoring | X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 Sy | October 30, 2015 |
| K131944 | jordan neuroscience | IEEG | April 10, 2014 |
| K130013 | advanced brain monitoring | X4 SYSTEM | January 31, 2013 |
| K120447 | advanced brain monitoring | X4 | June 20, 2012 |
| K110967 | neuralynx | ENTERPRISE ELECTROPHYSIOLOGY SYSTEM | June 30, 2011 |
| K092477 | neurowave systems | NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701 | October 29, 2010 |
| K060523 | cyberkinetics | NEUROPORT NEURAL SIGNAL PROCESSING SYSTEM | March 28, 2006 |