FDA 510(k) Application Details - K172858

Device Classification Name Neuroimaging Correlation Software For Electroencephalograph Or Magnetoencephalograph

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510(K) Number K172858
Device Name Neuroimaging Correlation Software For Electroencephalograph Or Magnetoencephalograph
Applicant Epilog
Vlasgaardstraat 52
Ghent 9000 BE
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Contact Gregor Strobbe
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Regulation Number 882.1400

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Classification Product Code OLX
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Date Received 09/20/2017
Decision Date 01/08/2018
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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