INTELLIVUE PATIENT MONITOR

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.

Pre-market Notification Details

Device IDK122439
510k NumberK122439
Device Name:INTELLIVUE PATIENT MONITOR
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR. 2 Boeblingen,  DE 71034
ContactHerbert Van Dyk
CorrespondentHerbert Van Dyk
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR. 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 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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-10
Decision Date2012-08-29
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.