INTELLIVUE PATIENT MONITOR MX400, INTELLIVUE PATIENT MONITOR MX450, INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT

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 Mx400, Intellivue Patient Monitor Mx450, Intellivue Patient Monitor Mx500, Intellivue Patient.

Pre-market Notification Details

Device IDK141015
510k NumberK141015
Device Name:INTELLIVUE PATIENT MONITOR MX400, INTELLIVUE PATIENT MONITOR MX450, INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 Boeblingen,  DE D 71034
ContactMarkus Stacha
CorrespondentMarkus Stacha
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 Boeblingen,  DE D 71034
Product CodeMHX  
Subsequent Product CodeDSJ
Subsequent Product CodeDSK
Subsequent Product CodeGWS
Subsequent Product CodeMLD
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-04-21
Decision Date2014-05-19
Summary:summary

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