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

System, Monitoring, Perinatal

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

Pre-market Notification Details

Device IDK092028
510k NumberK092028
Device Name:PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50
ClassificationSystem, Monitoring, Perinatal
Applicant PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR. 2 Boeblingen,  DE D-71034
ContactMichael Asmalsky
CorrespondentMichael Asmalsky
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR. 2 Boeblingen,  DE D-71034
Product CodeHGM  
CFR Regulation Number884.2740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-07-06
Decision Date2010-02-17
Summary:summary

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