510(k) Report

Devices descending from K002150

18 later devices reach Sonicaid FM820, Sonicaid FM830 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090285Sonicaid FM820 and FM830 EncoreHuntleigh Healthcare, Ltd.20094—
+1K040903Cadence, Models 2001 and 2002Edan Instruments, Inc.200412—
+2K200975Sonicaid Team3 Antepartum, Sonicaid Team3 IntrapartumHuntleigh Healthcare Limited20203—
+2K082369Cadence, Cadence Dual, Cadence II Fetal MonitorEdan Instruments, Inc.20084—
+2K073221Cadence IIEdan Instruments, Inc.200711—
+3K241368Sonicaid Team3Huntleigh Healthcare, Ltd.20252—
+3K112187FM-1000 Plus Fetal MonitorAdvanced Instrumentations, Inc.20110—
+3K102140Fetal Monitors, Models F2 and F3Edan Instruments, Inc.201131
+3K082602Fetal & Maternal Monitor, Model F6, F9Edan Instruments, Inc.20086—
+4K250777Sonicaid Team3Huntleigh Healthcare, Ltd.20251—
+4K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+4K141194FM-3000 Fetal MonitorAdvanced Instrumentations, Inc.20140—
+4K100797Fetal Maternal Monitor Model F9 Express and ExpressEdan Instruments, Inc.20105—
+5K253021ANNE MaternalSibel Health, Inc.20260—
+5K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+5K150901Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 ExpressEdan Instruments, Inc.201521
+5K131941Fetal MonitorsGuangdong Biolight Meditech Co., Ltd.20140—
+5K112317FM-9000 Plus Fetal and Maternal MonitorAdvanced Instrumentations, Inc.20110—