510(k) Report

Devices descending from K100797

5 later devices reach Fetal Maternal Monitor Model F9 Express and Express through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150901Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 ExpressEdan Instruments, Inc.201521
+1K131941Fetal MonitorsGuangdong Biolight Meditech Co., Ltd.20140—
+1K112317FM-9000 Plus Fetal and Maternal MonitorAdvanced Instrumentations, Inc.20110—
+2K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+3K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—