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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
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