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FDA 510(k) Application Details - K915820

Device Classification Name Non-Normalizing Quantitative Electroencephalograph Software

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510(K) Number K915820
Device Name Non-Normalizing Quantitative Electroencephalograph Software
Applicant LEXICOR MEDICAL TECHNOLOGY, INC.
2585 CENTRAL AVE.
BOULDER, CO US
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Contact KENNETH D NICHOLS
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Regulation Number 882.1400

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Classification Product Code OLT
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Date Received 12/30/1991
Decision Date 02/08/1995
Decision SE - Substantially Equivalent
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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