IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550

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 Mx500, Intellivue Patient Monitor Mx550.

Pre-market Notification Details

Device IDK192137
510k NumberK192137
Device Name:IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550
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)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-07
Decision Date2020-09-11

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.