510(k) Report

Devices descending from K030691

7 later devices reach Fetal Spiral Electrode, Model FSE07000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243291Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)Neoventa Medical AB20250—
+1K080672BirthtrackBarnev, Ltd.20085—
+2K082704Birthtrack (a.K.a. CLM)Barnev, Ltd.20094—
+3K103172Civ-OB (Plus)Civnet Communication, Ltd.20113—
+4K153580Central Monitoring SystemGuangdong Biolight Meditech Co., Ltd.20160—
+4K143695Central Monitoring SystemEdan Instruments, Inc.20151—
+5K171178Central Monitoring SystemEdan Instruments, Inc.201701