IntelliVue Multi-Measurement Module MMX

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 Multi-measurement Module Mmx.

Pre-market Notification Details

Device IDK181831
510k NumberK181831
Device Name:IntelliVue Multi-Measurement Module MMX
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 CodeDRQ
Subsequent Product CodeDSI
Subsequent Product CodeDSJ
Subsequent Product CodeDSK
Subsequent Product CodeDXG
Subsequent Product CodeDXN
Subsequent Product CodeMLD
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-07-09
Decision Date2018-11-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838086760 K181831 000

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