INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550

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 Mx500, Intellivue Patient Monitor Mx550.

Pre-market Notification Details

Device IDK131872
510k NumberK131872
Device Name:INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550
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  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-24
Decision Date2013-10-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838038783 K131872 000
00884838038776 K131872 000

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