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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 K904294
Device Name QSI 9500
Applicant
QUANTIFIED SIGNAL IMAGING, INC.
290 YORKLAND BLVD.
TORONTO,  CA M2J 1R5
Applicant Contact HOWARD GALIN
Correspondent
QUANTIFIED SIGNAL IMAGING, INC.
290 YORKLAND BLVD.
TORONTO,  CA M2J 1R5
Correspondent Contact HOWARD GALIN
Regulation Number882.1400
Classification Product Code
OLU  
Subsequent Product Codes
GWE   GWF   GWJ  
Date Received09/19/1990
Decision Date 07/30/1991
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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