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OLT — Non-Normalizing Quantitative Electroencephalograph Software Class II

FDA Device Classification

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-NumberApplicantDevice NameDate
K251881hippoclinicHippoMind (v1.0)December 3, 2025
K251366nihon kohden corporationEEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-October 9, 2025
K240593neuroservoVEEGix EEG SystemAugust 23, 2024
K220254neurosoftNeuron-Spectrum-AM with Neuron-Spectrum.NET SoftwareNovember 30, 2022
K213299pascall systemsWireless EEG SystemMay 11, 2022
K191322ge healthcare finlandE-EEGX, N-EEGXJanuary 22, 2020
K192572moberg researchCNS EnvisionDecember 17, 2019
K190760cadwell industriesCadwell Bolt SoftwareNovember 23, 2019
K143487kvikna ehfLifelines iEEGAugust 21, 2015
K142834neurowave systemsDiscoverEEG System, Model DE-401June 23, 2015
K133995neurosoftNEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWAREJune 19, 2015
K141316neuronetrix solutionsCOGNISION EEG/EP SYSTEMFebruary 13, 2015
K142064eb neuroGALILEO NTFebruary 13, 2015
K131882electrical geodesicsGEODESICEEG SYSTEM 400 SERIES (GES 400)February 12, 2014
K123665kvikna ehfLIFELINES IEEGMarch 25, 2013
K091963infinite biomedical technologiesVIGILANT EEG MONITOR, VIGILANT 2.0November 6, 2009
K082886brainscope companyZOOM-100DCAugust 10, 2009
K080546nihon kohden americaNIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200AAugust 29, 2008
K072382infinite biomedical technologiesMODEL I-2000 MONITORFebruary 15, 2008
K063797electrical geodesics, incorporatedGEODESIC EEG SYSTEM 300January 25, 2007