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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full-Montage Standard Electroencephalograph
510(k) Number K112817
Device Name MICROEEG SYSTEM
Applicant
Bio-Signal Group Corporation
760 Parkside Ave.
Brooklyn,  NY  11226
Applicant Contact ANDERSON MICU
Correspondent
Bio-Signal Group Corporation
760 Parkside Ave.
Brooklyn,  NY  11226
Correspondent Contact ANDERSON MICU
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received09/28/2011
Decision Date 06/19/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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