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 IDK131829
510k NumberK131829
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
ContactHerbert Van Dyk
CorrespondentHerbert Van Dyk
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 Boeblingen,  DE D 71034
Product CodeMHX  
Subsequent Product CodeBZC
Subsequent Product CodeBZQ
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 CodeDSF
Subsequent Product CodeDSH
Subsequent Product CodeDSI
Subsequent Product CodeDSJ
Subsequent Product Code&nb
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-20
Decision Date2013-08-16
Summary:summary

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