Cleared Traditional

EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)

K251366 · Nihon Kohden Corporation · Neurology

Oct 2025

Decision

161d

Days

Class 2

Risk

About This 510(k) Submission

K251366 is an FDA 510(k) clearance for the EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A), a Non-normalizing Quantitative Electroencephalograph Software (Class II — Special Controls, product code OLT), submitted by Nihon Kohden Corporation (Tokyo, JP). The FDA issued a Cleared decision on October 9, 2025, 161 days after receiving the submission on May 1, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K251366 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 2025
Decision Date	October 09, 2025
Days to Decision	161 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OLT — Non-normalizing Quantitative Electroencephalograph Software
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Analyze Electroencephalograph Data Using Conventional Methodology To Output And Display Standard Electroencephalograph Parameters For Interpretation By A Qualified User.