510(k) Report

Devices descending from K950420

4 later devices reach Fetalgard 3000 - Models IP1, IP2, AP2 and AP3 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K983395Fetalgard 3000 Fetal MonitorAnalogic Corp.19993—
+2K090145Surecall Emg Labor MonitorReproductive Research Technologies, LP20112—
+3K131889Eum 100PROPromedic, Inc.20140—
+3K130002Surecall Labor MonitorReproductive Research Technologies, LP20130—