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FDA 510(k) Application Details - K052362
Device Classification Name
Index-Generating Electroencephalograph Software
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510(K) Number
K052362
Device Name
Index-Generating Electroencephalograph Software
Applicant
ASPECT MEDICAL SYSTEMS, INC.
141 NEEDHAM ST.
NEWTON, MA 02464 US
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Contact
CHRISTINE VOZELLA
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Regulation Number
882.1400
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Classification Product Code
OLW
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More FDA Info for this Product Code
Date Received
08/29/2005
Decision Date
09/09/2005
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
Y
Expedited Review
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