OMC — Reduced- Montage Standard Electroencephalograph Class II
FDA product code OMC covers "Reduced- Montage Standard Electroencephalograph", a Class II medical device regulated under 21 CFR 882.1400. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K261101 | ceribell | Ceribell Monitor | June 30, 2026 |
| 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 |