IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot Module Rack FMX-4

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 Mx750, Intellivue Patient Monitor Mx850, Intellivue 4-slot Module Rack Fmx-4.

Pre-market Notification Details

Device IDK210906
510k NumberK210906
Device Name:IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot Module Rack FMX-4
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Strasse 2 Boeblingen,  DE 71034
ContactMonica Da Silva
CorrespondentMonica Da Silva
Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Strasse 2 Boeblingen,  DE 71034
Product CodeMHX  
Subsequent Product CodeBZC
Subsequent Product CodeBZQ
Subsequent Product CodeCBQ
Subsequent Product CodeCBR
Subsequent Product CodeCBS
Subsequent Product CodeCCK
Subsequent Product CodeCCL
Subsequent Product CodeDPS
Subsequent Product CodeDQA
Subsequent Product CodeDRT
Subsequent Product CodeDSF
Subsequent Product CodeDSJ
Subsequent Product CodeDSK
Subsequent Product CodeDXN
Subsequent Product CodeFLL
Subsequent Product CodeGWQ
Subsequent Product CodeGWS
Subsequent Product CodeKLK
Subsequent Product CodeKOI
Subsequent Product Code&nb
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-26
Decision Date2021-10-07

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