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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name monitor, physiological, patient(with arrhythmia detection or alarms)
510(k) Number K001722
Device Name AGILENT COMPONENT MONITORING SYSTEM; AGILENT INVASIVE BLOOD PRESSURE MODULE
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
MHX  
Date Received06/06/2000
Decision Date 06/30/2000
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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