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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K002758
Device Name AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A
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 Number870.1025
Classification Product Code
DSI  
Date Received09/05/2000
Decision Date 02/22/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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