FDA 510(k) Application Details - K051825

Device Classification Name Electroencephalograph

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510(K) Number K051825
Device Name Electroencephalograph
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 GWQ
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Date Received 07/05/2005
Decision Date 09/12/2005
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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