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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 K171414
Device Name qEEG-Pro
Applicant
Brainmaster Technologies, Inc.
195 Willis St., Suite 3
Bedford,  OH  44146
Applicant Contact Tom Collura
Correspondent
Mdi Consultants, Inc.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact Maria Griffin
Regulation Number882.1400
Classification Product Code
OLU  
Date Received05/15/2017
Decision Date 07/01/2018
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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