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510(k) K141316

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

K141316 is an FDA 510(k) premarket notification submitted by Neuronetrix Solutions for the device "COGNISION EEG/EP SYSTEM". The FDA issued a decision of Substantially Equivalent on February 13, 2015. The device falls under product code OLT (Non-Normalizing Quantitative Electroencephalograph Software), a Class II device regulated under 21 CFR 882.1400.

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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FDA data resources