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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 K141316
Device Name COGNISION EEG/EP SYSTEM
Applicant
Neuronetrix Solutions
816 Congress Ave. Suite 1400
Austin,  TX  78701
Applicant Contact CHERYL FISHER
Correspondent
Neuronetrix Solutions
816 Congress Ave. Suite 1400
Austin,  TX  78701
Correspondent Contact CHERYL FISHER
Regulation Number882.1400
Classification Product Code
OLT  
Subsequent Product Codes
GWJ   OMC  
Date Received05/20/2014
Decision Date 02/13/2015
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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