510(k) K141316

COGNISION EEG/EP SYSTEM by Neuronetrix Solutions — Product Code OLT

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 13, 2015
Date Received: May 20, 2014
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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