510(k) Report

Devices descending from K081203

7 later devices reach OB Tracevue Obstetrical Information Management System with Release F.00 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143695Central Monitoring SystemEdan Instruments, Inc.20151—
+1K100420Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH20104—
+2K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH20181—
+2K171178Central Monitoring SystemEdan Instruments, Inc.201701
+2K111083Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201111
+3K220732Mural Perinatal SurveillanceGe Medical Systems Information Technologies, Inc.20220—
+3K140535Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizin Systeme Boblingen GmbH201405