HBIDB – HUMAN BRIAN INDEX SOFTWARE


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

Correspodent Contact patrik r karem
Regulation Number 882.1400
Classification Product Code
OLU  
Date Received 07/21/2011
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