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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source Localization Software For Electroencephalograph Or Magnetoencephalograph
510(k) Number K002631
Device Name ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG
Applicant
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
W306 D8345 CHESNUT DR.
MUKWONAGO,  WI  53149
Applicant Contact SCOTT PEASE
Correspondent
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
W306 D8345 CHESNUT DR.
MUKWONAGO,  WI  53149
Correspondent Contact SCOTT PEASE
Regulation Number882.1400
Classification Product Code
OLX  
Date Received08/23/2000
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
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