FDA 510(k) Application Details - K050035

Device Classification Name Neuroimaging Correlation Software For Electroencephalograph Or Magnetoencephalograph

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510(K) Number K050035
Device Name Neuroimaging Correlation Software For Electroencephalograph Or Magnetoencephalograph
Applicant ELEKTA NEUROMAG OY
KUNGSTENSGATAN 18
PO BOX 7593
STOCKHOLM SE-103 93 SE
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Contact LOUISE LINDBLAD
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Regulation Number 882.1400

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Classification Product Code OLX
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Date Received 01/07/2005
Decision Date 01/25/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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