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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 K863650
Device Name QUANTIMAP III
Applicant
QUANTIFIED SIGNAL IMAGING, INC.
290 YORKLAND BLVD.
TORONTO,  CA M2J 1R5
Applicant Contact MICHAEL J CANNATA
Correspondent
QUANTIFIED SIGNAL IMAGING, INC.
290 YORKLAND BLVD.
TORONTO,  CA M2J 1R5
Correspondent Contact MICHAEL J CANNATA
Regulation Number882.1400
Classification Product Code
OLT  
Subsequent Product Codes
GWE   GWF   GWJ   GWQ  
Date Received09/18/1986
Decision Date 09/26/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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