OLT — Non-Normalizing Quantitative Electroencephalograph Software Class II
FDA product code OLT covers "Non-Normalizing Quantitative Electroencephalograph Software", 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
- OLT
- Device Class
- Class II
- Regulation Number
- 882.1400
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Definition
Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253767 | universal brain | UB ERP System | June 30, 2026 |
| K251881 | hippoclinic | HippoMind (v1.0) | December 3, 2025 |
| K251366 | nihon kohden corporation | EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS- | October 9, 2025 |
| K240593 | neuroservo | VEEGix EEG System | August 23, 2024 |
| K220254 | neurosoft | Neuron-Spectrum-AM with Neuron-Spectrum.NET Software | November 30, 2022 |
| K213299 | pascall systems | Wireless EEG System | May 11, 2022 |
| K191322 | ge healthcare finland | E-EEGX, N-EEGX | January 22, 2020 |
| K192572 | moberg research | CNS Envision | December 17, 2019 |
| K190760 | cadwell industries | Cadwell Bolt Software | November 23, 2019 |
| K143487 | kvikna ehf | Lifelines iEEG | August 21, 2015 |
| K142834 | neurowave systems | DiscoverEEG System, Model DE-401 | June 23, 2015 |
| K133995 | neurosoft | NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE | June 19, 2015 |
| K141316 | neuronetrix solutions | COGNISION EEG/EP SYSTEM | February 13, 2015 |
| K142064 | eb neuro | GALILEO NT | February 13, 2015 |
| K131882 | electrical geodesics | GEODESICEEG SYSTEM 400 SERIES (GES 400) | February 12, 2014 |
| K123665 | kvikna ehf | LIFELINES IEEG | March 25, 2013 |
| K091963 | infinite biomedical technologies | VIGILANT EEG MONITOR, VIGILANT 2.0 | November 6, 2009 |
| K082886 | brainscope company | ZOOM-100DC | August 10, 2009 |
| K080546 | nihon kohden america | NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A | August 29, 2008 |
| K072382 | infinite biomedical technologies | MODEL I-2000 MONITOR | February 15, 2008 |