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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
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