INTELLIVUE PATIENT MONITOR

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

PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN

The following data is part of a premarket notification filed by Philips Medizinsysteme Boeblingen Gmbh, Cardiac An with the FDA for Intellivue Patient Monitor.

Pre-market Notification Details

Device IDK093268
510k NumberK093268
Device Name:INTELLIVUE PATIENT MONITOR
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 Boeblingen,  DE D 71034
ContactAndreas Suchi
CorrespondentAndreas Suchi
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 Boeblingen,  DE D 71034
Product CodeMHX  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-10-19
Decision Date2010-05-11
Summary:summary

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