SCORE: see Cognision system w/AI and FDA 510K K141316 #issued...good information to have as we go forward here. This should indicate some evaluation of the overall system has been conducted and found to be safe and effective. We do not yet know if any validation of claims for medical device uses in AD clinical uses, but would guess that would be the very first thing Dr.M. would ask.(anyone know how to get copy of FDA product test investigation w/o FOIA?) More evaluation before the use of the system as biomarker source for AD. DO NOT KNOW THAT YET, BUT THE POSSIBILITY SUGGESTS ITSELF. Could be a very NICE piece of technology for our purposes. This might also splain a few things.
Keep digging everyone, there's a pony in here somewhere.
Device Classification Name non-normalizing quantitative electroencephalograph software 510(k) Number K141316 Device Name COGNISION EEG/EP SYSTEM Applicant NEURONETRIX SOLUTIONS 816 CONGRESS AVENUE, SUITE 1400 austin, TX 78701 Applicant Contact cheryl fisher Correspondent NEURONETRIX SOLUTIONS 816 CONGRESS AVENUE, SUITE 1400 austin, TX 78701 Correspondent Contact cheryl fisher Regulation Number 882.1400 Classification Product Code OLT Subsequent Product Codes GWJ OMC Date Received 05/20/2014 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
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