FDA 510(k) Application Details - K002631

Device Classification Name Neuroimaging Correlation Software For Electroencephalograph Or Magnetoencephalograph

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510(K) Number K002631
Device Name Neuroimaging Correlation Software For Electroencephalograph Or Magnetoencephalograph
Applicant EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
W306 D8345 CHESNUT DR.
MUKWONAGO, WI 53149 US
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Contact SCOTT PEASE
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Regulation Number 882.1400

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Classification Product Code OLX
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Date Received 08/23/2000
Decision Date 10/23/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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