510(k) K133995

NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE by Neurosoft , Ltd. — Product Code OLT

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 19, 2015
Date Received: December 26, 2013
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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