Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 And X2 Multi-msrmt-modules For Use With IntelliVue Patient Monitors

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

PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH

The following data is part of a premarket notification filed by Philips Medizin Systeme Boeblingen Gmbh with the FDA for Philips Intellivue Mp2/mp5/mpsc Patient Monitors, Philips Intellivue X1 And X2 Multi-msrmt-modules For Use With Intellivue Patient Monitors.

Pre-market Notification Details

Device IDK150975
510k NumberK150975
Device Name:Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 And X2 Multi-msrmt-modules For Use With IntelliVue Patient Monitors
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH Hewlett-Packard Str. 2 Boeblingen, Baden Wuerttemberg,  DE 71034
ContactMichael Asmalsky
CorrespondentMichael Asmalsky
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH Hewlett-Packard Str. 2 Boeblingen, Baden Wuerttemberg,  DE 71034
Product CodeMHX  
Subsequent Product CodeDQA
Subsequent Product CodeDSB
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-04-13
Decision Date2015-06-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838055094 K150975 000

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