510(k) Report

Devices descending from K092028

3 later devices reach Philips Avalon Fetal Monitors FM20, FM30, FM40, and FM50 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102958Philips Avalon Fetal MonitorPhilips Medizin Systeme Boblingen GmbH20112—
+2K111083Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201111
+3K140535Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizin Systeme Boblingen GmbH201405