510(k) Report

Devices descending from K934959

25 later devices reach Model 118 Fetal/Maternal Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052544Pulse Oximeter Adapter CablesAmerican I.V. Products, Inc.20060—
+1K994008Biosys Fetal Monitor, Model Ifm-500Biosys Co., Ltd.20006—
+1K992811Transducers for Ultrasound and Tocodynamometer Fetal MonitoringEpic Medical Equipment Services, Inc.20002—
+1K964770Corometrics 120 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies199716—
+2K110612FM20Mediana Co., Ltd.20110—
+2K103545BT-350Bistos Co., Ltd.20110—
+2K052190Fetal Monitor, Models BT-300 and BT-200Bistos Co., Ltd.20053—
+2K043075Tenacore Transducers for Fetal Ultrasonic and Tokodynamometer MonitoringTenacore Holdings, Inc.20050—
+2K040392Transducers for Ultrasound and Tocodynamometer Fetal MonitoringAmerican I.V. Products, Inc.20040—
+2K012718Modification to Corometrics Model 120IS Maternal/Fetal Monitoring System.Ge Medical Systems Information Technologies2001115
+2K991739Corometrics 120 Series Maternal/Fetal MonitorGeneral Electric Medical Systems Information Techn199910—
+3K110630F10Mediana Co., Ltd.20110—
+3K100797Fetal Maternal Monitor Model F9 Express and ExpressEdan Instruments, Inc.20105—
+3K100885Fetal Monitor Model: BT-200TBistos Co., Ltd.20101—
+3K082602Fetal & Maternal Monitor, Model F6, F9Edan Instruments, Inc.20086—
+3K032252Model 120 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies20032—
+3K021135Model 2120IS Series Maternal/Fetal MonitorGe Medical Systems Information Technologies200201
+4K142799Model BT-220L and BT-220CBistos Co., Ltd.20150—
+4K150901Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 ExpressEdan Instruments, Inc.201521
+4K131941Fetal MonitorsGuangdong Biolight Meditech Co., Ltd.20140—
+4K112317FM-9000 Plus Fetal and Maternal MonitorAdvanced Instrumentations, Inc.20110—
+4K050583Model 250 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies20051—
+5K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+5K072976Model 250CX Series Maternal/Fetal MonitorGE Healthcare20070—
+6K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—