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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 K000822
Device Name AGILENTCOMPONENT MONITORING SYSTEM, AGILENT 24/26, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR
Applicant
AGILENT TECHNOLOGIES, GMBH
HERRENBERGERSTR. 130
BOEBLINGEN,  DE 71034
Applicant Contact EGON PFEIL
Correspondent
AGILENT TECHNOLOGIES, GMBH
HERRENBERGERSTR. 130
BOEBLINGEN,  DE 71034
Correspondent Contact EGON PFEIL
Regulation Number870.1025
Classification Product Code
DSI  
Date Received03/14/2000
Decision Date 04/06/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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