FDA 510(k) Application Details - K072382

Device Classification Name Non-Normalizing Quantitative Electroencephalograph Software

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510(K) Number K072382
Device Name Non-Normalizing Quantitative Electroencephalograph Software
Applicant INFINITE BIOMEDICAL TECHNOLOGIES
3600 CLIPPER MILL ROAD
SUITE 410
BALTIMORE, MD 21211 US
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Contact MANAN HATHI
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Regulation Number 882.1400

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Classification Product Code OLT
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Date Received 08/24/2007
Decision Date 02/15/2008
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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