OLT · Non-Normalizing Quantitative Electroencephalograph Software
Neurology · 21 CFR 882.1400 · Class 2
Overview
| Product Code | OLT |
|---|---|
| Device Name | Non-Normalizing Quantitative Electroencephalograph Software |
| Regulation | 21 CFR 882.1400 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 54)
Showing 20 most recent of 54 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251881 | HippoMind (v1.0) | Hippoclinic | Dec 3, 2025 | SESE |
| K251366 | EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) | Nihon Kohden Corporation | Oct 9, 2025 | SESE |
| K240593 | VEEGix EEG System | NeuroServo, Inc. | Aug 23, 2024 | SESE |
| K220254 | Neuron-Spectrum-AM with Neuron-Spectrum.NET Software | Neurosoft , Ltd. | Nov 30, 2022 | SESE |
| K213299 | Wireless EEG System | Pascall Systems, Inc. | May 11, 2022 | SESE |
| K191322 | E-EEGX, N-EEGX | GE Healthcare Finland Oy | Jan 22, 2020 | SESE |
| K192572 | CNS Envision | Moberg Research, Inc. | Dec 17, 2019 | SESE |
| K190760 | Cadwell Bolt Software | Cadwell Industries, Inc. | Nov 23, 2019 | SESE |
| K143487 | Lifelines iEEG | Kvikna Ehf | Aug 21, 2015 | SESE |
| K142834 | DiscoverEEG System, Model DE-401 | Neurowave Systems, Inc. | Jun 23, 2015 | SESE |
| K133995 | NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE | Neurosoft , Ltd. | Jun 19, 2015 | SESE |
| K142064 | GALILEO NT | Eb Neuro S.P.A. | Feb 13, 2015 | SESE |
| K141316 | COGNISION EEG/EP SYSTEM | Neuronetrix Solutions | Feb 13, 2015 | SESE |
| K131882 | GEODESICEEG SYSTEM 400 SERIES (GES 400) | Electrical Geodesics, Inc. | Feb 12, 2014 | SESE |
| K123665 | LIFELINES IEEG | Kvikna Ehf | Mar 25, 2013 | SESE |
| K091963 | VIGILANT EEG MONITOR, VIGILANT 2.0 | Infinite Biomedical Technologies, LLC | Nov 6, 2009 | SESE |
| K082886 | ZOOM-100DC | Brainscope Company, Inc. | Aug 10, 2009 | SESE |
| K080546 | NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A | Nihon Kohden America, Inc. | Aug 29, 2008 | SESE |
| K072382 | MODEL I-2000 MONITOR | Infinite Biomedical Technologies | Feb 15, 2008 | SESE |
| K063797 | GEODESIC EEG SYSTEM 300 | Electrical Geodesics, Incorporated | Jan 25, 2007 | SESE |
Top Applicants
- Aspect Medical Systems, Inc. — 2 clearances
- Brainz Instruments , Ltd. — 2 clearances
- Kvikna Ehf — 2 clearances
- Medelec , Ltd. — 2 clearances
- Neuro Scan Labs — 2 clearances
