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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 K150498
Device Name Discovery 24
Applicant
BRAINMASTER TECHNOLOGIES, INC.
195 Willis Street, Suite 3
Bedford,  OH  44146
Applicant Contact Mr. Tom Collura
Correspondent
MDI CONSULTANTS, INC
55 NORTHERN BLVD. STE 200
GREAT NECK,  NY  11021
Correspondent Contact Ms. Maria F. Griffin
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received02/26/2015
Decision Date 01/26/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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