PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50

System, Monitoring, Perinatal

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 Philips Avalon Fetal/maternal Monitors Fm20, Fm30, Fm40 And Fm50.

Pre-market Notification Details

Device IDK111083
510k NumberK111083
Device Name:PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50
ClassificationSystem, Monitoring, Perinatal
Applicant PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 Boeblingen,  DE D 71034
ContactMichael Asmalsky
CorrespondentMichael Asmalsky
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 Boeblingen,  DE D 71034
Product CodeHGM  
CFR Regulation Number884.2740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-04-19
Decision Date2011-08-17
Summary:summary

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