510(k) Report

Devices descending from K040480

21 later devices reach Sonotrax Ultrasonic Pocket Doppler through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110630F10Mediana Co., Ltd.20110—
+1K090510Doppler Fetal Heartbeat Rate DetectorShenzhen Bestman Instrument Co., Ltd.20101—
+1K082055Model PC-860 Fetal DopplerShenzhen Creative Industry Co., Ltd.20090—
+1K080087Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite, Basic, Pro, II, II…Edan Instruments, Inc.200813—
+1K052190Fetal Monitor, Models BT-300 and BT-200Bistos Co., Ltd.20053—
+2K242846Doppler FHR Detector (BF-500D+, BF-560)Shenzhen Bestman Instrument Co., Ltd.20250—
+2K102138Ultrasonic Tabletop Doppler; Ultrasonic Tabletop DopplerEdan Instruments, Inc.20105—
+2K101960Sonotrax Series Ultrasonic Pocket DopplerEdan Instruments, Inc.20104—
+2K100885Fetal Monitor Model: BT-200TBistos Co., Ltd.20101—
+2K092997Ultrasonic Tabletop Doppler, Models SD5 and SD6Edan Instruments, Inc.20097—
+3K153475SD5 & SD6 Ultrasonic Tabletop DopplerEdan Instruments, Inc.20164—
+3K142799Model BT-220L and BT-220CBistos Co., Ltd.20150—
+3K140579Ultrasonic Pocket DopplerEdan Instruments, Inc.20153—
+3K112529TD-5000 & TD-6000 Ultrasonic Tabletop DopplerAdvanced Instrumentations, Inc.20110—
+4K212084Fetal DopplerShenzhen Mericonn Technology Co., Ltd.20210—
+4K191388FloPatch (FP110)Flosonics Medical (R/A 1929803 Ontario Corp.)20191—
+4K180419Ultrasonic Doppler (Model YM-2T8)Shenzhen Imdk Medical Technology Co., Ltd.20182—
+4K172780SD1 Ultrasonic Pocket DopplerEdan Instruments, Inc.20180—
+5K242487Laminar P1 (LDH-HW-001)Laminar Digital Health, Inc.20240—
+5K182710Fetal Doppler, Model FD88Shenzzhen Luckcome Technology Inc., Ltd.20190—
+5K182190Fetal DopplerShenzhen AOJ Medical Technology Co., Ltd.20180—