IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension

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 Monitor Mx100, Intellivue Multi-measurement Module X3, Intellivue Microstream Extension.

Pre-market Notification Details

Device IDK181314
510k NumberK181314
Device Name:IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 Boeblingen,  DE 71034
ContactStefan Breuer
CorrespondentStefan Breuer
Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 Boeblingen,  DE 71034
Product CodeMHX  
Subsequent Product CodeDSI
Subsequent Product CodeDSJ
Subsequent Product CodeDSK
Subsequent Product CodeDXG
Subsequent Product CodeDXN
Subsequent Product CodeKRB
Subsequent Product CodeMLD
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-05-17
Decision Date2018-09-04
Summary:summary

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