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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 K003038
Device Name AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A
Applicant
AGILENT TECHNOLOGIES DEUTSCHLAND GMBH
HERRENBERGER ST. 130
BOEBLINGEN
BOEBLINGEN,,  DE 71034
Applicant Contact EGON PFEIL
Correspondent
AGILENT TECHNOLOGIES DEUTSCHLAND GMBH
HERRENBERGER ST. 130
BOEBLINGEN
BOEBLINGEN,,  DE 71034
Correspondent Contact EGON PFEIL
Regulation Number882.1400
Classification Product Code
OLW  
Subsequent Product Codes
OLT   OMC   ORT  
Date Received09/29/2000
Decision Date 12/15/2000
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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