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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
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