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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Normalizing Quantitative Electroencephalograph Software
510(k) Number K112077
Device Name HBIDB - HUMAN BRIAN INDEX SOFTWARE
Applicant
CORSCIENCE GMBH & CO. KG
700-706 SECO RD
MONROEVILLE,  PA  15146
Applicant Contact PATRIK R KAREM
Correspondent
CORSCIENCE GMBH & CO. KG
700-706 SECO RD
MONROEVILLE,  PA  15146
Correspondent Contact PATRIK R KAREM
Regulation Number882.1400
Classification Product Code
OLU  
Date Received07/21/2011
Decision Date 03/09/2012
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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