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FDA 510(k) Application Details - K002631
Device Classification Name
Neuroimaging Correlation Software For Electroencephalograph Or Magnetoencephalograph
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
882.1400
More FDA Info for this Regulation Number
Classification Product Code
OLX
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More FDA Info for this Product Code
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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