ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG


the company

Device Classification Name

source localization software for electroencephalograph or magnetoencephalograph

510(k) Number K002631
Device Name ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG
Original Applicant
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
w306 d8345 chesnut dr.
mukwonago, 
WI 
53149

Original Contact scott pease
Regulation Number 882.1400
Classification Product Code
OLX  
Date Received 08/23/2000
Decision Date 10/23/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

Type Traditional
Reviewed by Third Party No

Combination Product

No