IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3

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 Intellivue Patient Monitors Mx100, Mx400, Mx430, Mx450, Mx500, Mx550, Intellivue Patient Monitors Mx700, Mx800, Intellivue Patient Monitors Mp5, Mp5sc, Multi-measurement Module X3.

Pre-market Notification Details

Device IDK182979
510k NumberK182979
Device Name:IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard Str. 2 Boeblingen,  DE 71034
ContactMarkus Stacha
CorrespondentMarkus Stacha
Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard Str. 2 Boeblingen,  DE 71034
Product CodeMHX  
Subsequent Product CodeDRT
Subsequent Product CodeDSI
Subsequent Product CodeDSJ
Subsequent Product CodeDSK
Subsequent Product CodeDXN
Subsequent Product CodeMLD
Subsequent Product CodeMSX
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-10-26
Decision Date2019-11-19
Summary:summary

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