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FDA 510(k) Application Details - K952347
Device Classification Name
Non-Normalizing Quantitative Electroencephalograph Software
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510(K) Number
K952347
Device Name
Non-Normalizing Quantitative Electroencephalograph Software
Applicant
ASPECT MEDICAL SYSTEMS, INC.
2 VISION DR.
NATICK, MA 01760-2059 US
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Contact
M. CHRISTINE MORGIDA
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Regulation Number
882.1400
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Classification Product Code
OLT
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Date Received
05/19/1995
Decision Date
01/16/1996
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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