510(k) Report

Devices descending from K100626

9 later devices reach Doppler Fetal Heart Rate Detector, Model FM-200 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112911Fetal DopplerBeijing Choice Electronic Technololgy Co., Ltd.20118—
+2K191110HeraBEAT™ USHeramed, Ltd.20190—
+2K131457Fetal Ultrasonic Monitor and AccessoriesShenzhen Jumper Medical Equipment Co., Ltd.20146—
+3K182526Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B…Vcomin Technology Limited20194—
+3K172780SD1 Ultrasonic Pocket DopplerEdan Instruments, Inc.20180—
+4K220245Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)Contec Medical Systems Co.,Ltd20221—
+4K211940Fetal DopplerShenzhen Taikang Medical Equipment Co., Ltd.20221—
+5K252669Fetal Doppler U8-25, U9-25Zhongshan Xiaolan Town Senlan Electronic Factory20260—
+5K232893Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal…Contec Medical Systems Co.,Ltd20240—