AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154

Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

AGILENT TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Agilent Technologies, Inc. with the FDA for Agilent Information Center Software For M3150,m3151,m3153 And M3154.

Pre-market Notification Details

Device IDK011093
510k NumberK011093
Device Name:AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant AGILENT TECHNOLOGIES, INC. 3000 MINUTEMAN RD. Andover,  MA  01810 -1099
ContactDave Osborn
CorrespondentDave Osborn
AGILENT TECHNOLOGIES, INC. 3000 MINUTEMAN RD. Andover,  MA  01810 -1099
Product CodeMHX  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-04-10
Decision Date2001-05-01

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