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FDA 510(k) Application Details - K121119
Device Classification Name
Normalizing Quantitative Electroencephalograph Software
More FDA Info for this Device
510(K) Number
K121119
Device Name
Normalizing Quantitative Electroencephalograph Software
Applicant
EIMINDA LTD.
16 HAMINHARA ST.
BEIT BACHAR
HERZLIYA 46586 IL
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Contact
DALIA DICKMAN
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Regulation Number
882.1400
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Classification Product Code
OLU
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More FDA Info for this Product Code
Date Received
04/12/2012
Decision Date
07/25/2014
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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