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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 K001333
Device Name AGILENT COMPONENT MONITORING SYSTEM, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR, AGILENT NONI
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 Received04/27/2000
Decision Date 05/17/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
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