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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 K853420
Device Name CARTOVAR BRAIN MAPPING ELECTRODIAGNOSTICS
Applicant
Alvar
1535 Lake Cook Rd., Suite 206
Northbrook,  IL  60062
Applicant Contact RICHARD C SAUL
Correspondent
Alvar
1535 Lake Cook Rd., Suite 206
Northbrook,  IL  60062
Correspondent Contact RICHARD C SAUL
Regulation Number882.1400
Classification Product Code
OLT  
Date Received08/14/1985
Decision Date 02/07/1986
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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