INTELLIVUE PATIENT MONITOR

Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN

The following data is part of a premarket notification filed by Philips Medizinsysteme Boeblingen Gmbh, Cardiac An with the FDA for Intellivue Patient Monitor.

Pre-market Notification Details

Device IDK120366
510k NumberK120366
Device Name:INTELLIVUE PATIENT MONITOR
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 Boeblingen,  DE D 71034
ContactMarkus Stacha
CorrespondentMarkus Stacha
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 Boeblingen,  DE D 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 CodeDRG
Subsequent Product CodeDRJ
Subsequent Product CodeDRQ
Subsequent Product CodeDRS
Subsequent Product CodeDRT
Subsequent Product CodeDRW
Subsequent Product CodeDSA
Subsequent Product CodeDSB
Subsequent Product CodeDSF
Subsequent Product CodeDSH
Subsequent Product Code&nb
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-02-06
Decision Date2012-07-18
Summary:summary

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