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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 K202588
Device Name BNA Platform
Applicant
elminda, Ltd
1 Arie Skenkar Street
Herzliya,  IL 4672501
Applicant Contact Keren Elghouzzi-Kazachinsky
Correspondent
Biologics Consulting
1555 King Street, Suite 300
Alexandria,  VA  22314
Correspondent Contact Donna-Bea Tillman
Regulation Number882.1400
Classification Product Code
OLU  
Date Received09/08/2020
Decision Date 12/07/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT01460394
NCT01532271
NCT01535339
NCT01671761
NCT01673464
NCT01759173
NCT01923441
NCT02105935
NCT02418208
NCT02875496
Reviewed by Third Party No
Combination Product No
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