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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 K212684
Device Name BrainView QEEG Software
Medeia, Inc.
7 W Figueroa St, Suite 300
Santa Barbara,  CA  93101
Applicant Contact Slav Danev
Compliance and Regulatory Services LLC
3771 Southbrook Dr
Dayton,  OH  45430
Correspondent Contact Daniel Lehtonen
Regulation Number882.1400
Classification Product Code
Date Received08/24/2021
Decision Date 01/28/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No