510(k) Report

Devices descending from K852608

32 later devices reach Spectra 400 Extended Surveillance & Alert System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K993008Quantitative Sentinel SystemMarquette Medical Systems, Inc.199993
+1K991905Corometrics Model 171 and 172 Fetal MonitorGeneral Electric Medical Systems Information Techn199916—
+1K991739Corometrics 120 Series Maternal/Fetal MonitorGeneral Electric Medical Systems Information Techn199910—
+1K963608Quantitative Sentinel SystemQuantitative Medicine, Inc.199710—
+2K100797Fetal Maternal Monitor Model F9 Express and ExpressEdan Instruments, Inc.20105—
+2K082602Fetal & Maternal Monitor, Model F6, F9Edan Instruments, Inc.20086—
+2K051175Civ-OB Obstrical Monitoring Software ApplicationCivent Communications, Ltd.20064—
+2K043597FC 700 Fetal MonitorBionet Co., Ltd.20051—
+2K040903Cadence, Models 2001 and 2002Edan Instruments, Inc.200412—
+2K032252Model 120 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies20032—
+2K020661Unity IS Patient ViewerGeneral Electric Medical Systems Information Techn20021—
+2K012718Modification to Corometrics Model 120IS Maternal/Fetal Monitoring System.Ge Medical Systems Information Technologies2001115
+2K993751Corometrics Model 173 Fetal MonitorGe Medical Systems Information Technologies20000—
+3K150901Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 ExpressEdan Instruments, Inc.201521
+3K131941Fetal MonitorsGuangdong Biolight Meditech Co., Ltd.20140—
+3K123335Sunray Fetal MonitorSunray Medical Apparatus Co., Ltd.20130—
+3K112317FM-9000 Plus Fetal and Maternal MonitorAdvanced Instrumentations, Inc.20110—
+3K103172Civ-OB (Plus)Civnet Communication, Ltd.20113—
+3K082369Cadence, Cadence Dual, Cadence II Fetal MonitorEdan Instruments, Inc.20084—
+3K073221Cadence IIEdan Instruments, Inc.200711—
+3K050583Model 250 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies20051—
+3K032346Unity Network IS Patient ViewerGe Medical Systems Information Technologies20030—
+3K021135Model 2120IS Series Maternal/Fetal MonitorGe Medical Systems Information Technologies200201
+4K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+4K153580Central Monitoring SystemGuangdong Biolight Meditech Co., Ltd.20160—
+4K143695Central Monitoring SystemEdan Instruments, Inc.20151—
+4K112187FM-1000 Plus Fetal MonitorAdvanced Instrumentations, Inc.20110—
+4K102140Fetal Monitors, Models F2 and F3Edan Instruments, Inc.201131
+4K072976Model 250CX Series Maternal/Fetal MonitorGE Healthcare20070—
+5K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+5K171178Central Monitoring SystemEdan Instruments, Inc.201701
+5K141194FM-3000 Fetal MonitorAdvanced Instrumentations, Inc.20140—