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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Non-Normalizing Quantitative Electroencephalograph Software
510(k) Number K251366
Device Name EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)
Applicant
Nihon Kohden Corporation
1-31-4 Nishiochiai, Shinijuku-Ku
Tokyo,  JP 161-8560
Applicant Contact Sandra Gadeyne
Correspondent
Nihon Kohden America, LLC
15353 Barranca Pkwy.
Irvine,  CA  92618
Correspondent Contact Charlemagne Chua
Regulation Number882.1400
Classification Product Code
OLT  
Subsequent Product Codes
GWE   GWQ   OLV  
Date Received05/01/2025
Decision Date 10/09/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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