510(k) Report

Devices descending from K131457

6 later devices reach Fetal Ultrasonic Monitor and Accessories through their predicates, nearest generation first.

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