FDA 510(k) Application Details - K984401

Device Classification Name Neuroimaging Correlation Software For Electroencephalograph Or Magnetoencephalograph

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510(K) Number K984401
Device Name Neuroimaging Correlation Software For Electroencephalograph Or Magnetoencephalograph
Applicant PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 MINER RD.
HIGHLAND HEIGHTS, OH 44143 US
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Contact ELAINE K KEELER
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Regulation Number 882.1400

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Classification Product Code OLX
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Date Received 12/09/1998
Decision Date 12/30/1998
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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