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FDA 510(k) Application Details - K142064
Device Classification Name
Non-Normalizing Quantitative Electroencephalograph Software
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510(K) Number
K142064
Device Name
Non-Normalizing Quantitative Electroencephalograph Software
Applicant
EB NEURO, S.P.A.
9001 WESLEYAN RD, STE 200
INDIANAPOLIS, IN 46268 US
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Contact
ALLISON SCOTT, RAC
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Regulation Number
882.1400
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Classification Product Code
OLT
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More FDA Info for this Product Code
Date Received
07/30/2014
Decision Date
02/13/2015
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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