FDA 510(k) Application Details - K070358

Device Classification Name Neuroimaging Correlation Software For Electroencephalograph Or Magnetoencephalograph

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510(K) Number K070358
Device Name Neuroimaging Correlation Software For Electroencephalograph Or Magnetoencephalograph
Applicant EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
PO BOX 7007
DEERFIELD, IL 60015 US
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Contact DANIEL KAMM
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Regulation Number 882.1400

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Classification Product Code OLX
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Date Received 02/07/2007
Decision Date 07/30/2007
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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