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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name normalizing quantitative electroencephalograph software
510(k) Number K121119
Device Name BNA ANALYSIS SYSTEM
Original Applicant
EIMINDA LTD.
16 haminhara st.
beit bachar
herzliya,  IS 46586
Original Contact dalia dickman
Regulation Number882.1400
Classification Product Code
OLU  
Date Received04/12/2012
Decision Date 07/25/2014
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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