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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full-Montage Standard Electroencephalograph
510(k) Number K192753
Device Name NeuralScan System
Applicant
Medeia, Inc.
7 W Figueroa St., Suites 300
Santa Barbara,  CA  93101
Applicant Contact Slav Danev
Correspondent
Compliance and Regulatory Services, LLC
3771 Southbrook Dr.
Dayton,  OH  45430
Correspondent Contact Daniel Lehtonen
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Codes
GWJ   OLT  
Date Received09/30/2019
Decision Date 03/17/2020
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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