510(k) Report

Devices descending from K002503

4 later devices reach Fetalgard Lite through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051903Fetalgard Lite-Nibp, Model FGL-NibpAnalogic Corporation20050—
+1K043598FC 1400 Fetal MonitorBionet Co., Ltd.20051—
+1K050234Remote CareE.Care Solutions, Inc.20050—
+2K123335Sunray Fetal MonitorSunray Medical Apparatus Co., Ltd.20130—