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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Index-Generating Electroencephalograph Software
510(k) Number K033543
Device Name NARCOTREND, MODEL COMPACT 4.0
Applicant
MT MONITORTECHNIK GMBH & CO. KG
MAIENBAS 27
BAD BRAMSTEDT,  DE D-24576
Applicant Contact FRIEDMUND WIELAND
Correspondent
MT MONITORTECHNIK GMBH & CO. KG
MAIENBAS 27
BAD BRAMSTEDT,  DE D-24576
Correspondent Contact FRIEDMUND WIELAND
Regulation Number882.1400
Classification Product Code
OLW  
Subsequent Product Codes
OLT   OMC  
Date Received11/10/2003
Decision Date 09/17/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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