FDA 510(k) Application Details - K072286

Device Classification Name Index-Generating Electroencephalograph Software

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510(K) Number K072286
Device Name Index-Generating Electroencephalograph Software
Applicant ASPECT MEDICAL SYSTEMS, INC.
1 UPLAND ROAD
NORWOOD, MA 02062 US
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Contact VIKRAM VERMA
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Regulation Number 882.1400

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Classification Product Code OLW
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Date Received 08/16/2007
Decision Date 11/20/2007
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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