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510(k) K251366

EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) by Nihon Kohden Corporation — Product Code OLT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2025
Date Received
May 1, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Non-Normalizing Quantitative Electroencephalograph Software
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.

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