FDA 510(k) Application Details - K041264

Device Classification Name Neuroimaging Correlation Software For Electroencephalograph Or Magnetoencephalograph

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510(K) Number K041264
Device Name Neuroimaging Correlation Software For Electroencephalograph Or Magnetoencephalograph
Applicant ELEKTA NEUROMAG OY
ELIMAENKATU 22 B, PO BX 68
HELSINKI FIN-00511 FI
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Contact BIRGITTA FAGERSTROM
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Regulation Number 882.1400

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Classification Product Code OLX
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Date Received 05/12/2004
Decision Date 08/10/2004
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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