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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Non-Normalizing Quantitative Electroencephalograph Software
510(k) Number K860378
Device Name MIND MAP (20 CHANNEL EEG)
Applicant
Mind Systems Corp.
590 W. End Ave.
Suite 12c
New York,  NY  10024
Applicant Contact WILLIAM J MOUSTAKIS
Correspondent
Mind Systems Corp.
590 W. End Ave.
Suite 12c
New York,  NY  10024
Correspondent Contact WILLIAM J MOUSTAKIS
Regulation Number882.1400
Classification Product Code
OLT  
Subsequent Product Codes
GWE   GWF   GWJ   GWQ  
Date Received02/03/1986
Decision Date 08/12/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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