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

System, Monitoring, Perinatal

PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH

The following data is part of a premarket notification filed by Philips Medizin Systeme Boblingen Gmbh with the FDA for Philips Avalon Fetal / Maternal Monitors Fm20, Fm30, Fm40 And Fm50.

Pre-market Notification Details

Device IDK140535
510k NumberK140535
Device Name:PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50
ClassificationSystem, Monitoring, Perinatal
Applicant PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH HEWLETT-PACKARD-STR. 2 Boblingen,  DE D-71034
ContactMichael Asmalsky
CorrespondentMichael Asmalsky
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH HEWLETT-PACKARD-STR. 2 Boblingen,  DE D-71034
Product CodeHGM  
Subsequent Product CodeDQA
Subsequent Product CodeDRG
Subsequent Product CodeDRQ
Subsequent Product CodeDRS
Subsequent Product CodeDRT
Subsequent Product CodeDSA
Subsequent Product CodeDSF
Subsequent Product CodeDSI
Subsequent Product CodeDSJ
Subsequent Product CodeDSK
Subsequent Product CodeDXG
Subsequent Product CodeDXN
Subsequent Product CodeDXQ
Subsequent Product CodeFLL
Subsequent Product CodeHFM
Subsequent Product CodeHFN
Subsequent Product CodeHGL
Subsequent Product CodeJOM
Subsequent Product CodeMSX
Subsequent Product Code&nb
CFR Regulation Number884.2740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-03-04
Decision Date2014-11-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838034259 K140535 000
00884838000407 K140535 000
00884838000414 K140535 000
00884838000421 K140535 000
00884838000438 K140535 000
00884838001404 K140535 000
00884838001411 K140535 000
00884838002715 K140535 000
00884838002722 K140535 000
00884838009950 K140535 000
00884838009974 K140535 000
00884838010338 K140535 000
00884838012141 K140535 000
00884838021471 K140535 000
00884838021488 K140535 000
00884838034228 K140535 000
00884838034235 K140535 000
00884838034242 K140535 000
20884838059324 K140535 000

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