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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
Applicant
Eiminda , Ltd.
16 Haminhara St.
Beit Bachar
Herzliya,  IL 46586
Applicant Contact DALIA DICKMAN
Correspondent
Eiminda , Ltd.
16 Haminhara St.
Beit Bachar
Herzliya,  IL 46586
Correspondent Contact DALIA DICKMAN
Regulation Number882.1400
Classification Product Code
OLU  
Date Received04/12/2012
Decision Date 07/25/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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