510(k) Report

Devices descending from K080087

13 later devices reach Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite, Basic… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102138Ultrasonic Tabletop Doppler; Ultrasonic Tabletop DopplerEdan Instruments, Inc.20105—
+1K101960Sonotrax Series Ultrasonic Pocket DopplerEdan Instruments, Inc.20104—
+1K092997Ultrasonic Tabletop Doppler, Models SD5 and SD6Edan Instruments, Inc.20097—
+2K153475SD5 & SD6 Ultrasonic Tabletop DopplerEdan Instruments, Inc.20164—
+2K140579Ultrasonic Pocket DopplerEdan Instruments, Inc.20153—
+2K112529TD-5000 & TD-6000 Ultrasonic Tabletop DopplerAdvanced Instrumentations, Inc.20110—
+3K212084Fetal DopplerShenzhen Mericonn Technology Co., Ltd.20210—
+3K191388FloPatch (FP110)Flosonics Medical (R/A 1929803 Ontario Corp.)20191—
+3K180419Ultrasonic Doppler (Model YM-2T8)Shenzhen Imdk Medical Technology Co., Ltd.20182—
+3K172780SD1 Ultrasonic Pocket DopplerEdan Instruments, Inc.20180—
+4K242487Laminar P1 (LDH-HW-001)Laminar Digital Health, Inc.20240—
+4K182710Fetal Doppler, Model FD88Shenzzhen Luckcome Technology Inc., Ltd.20190—
+4K182190Fetal DopplerShenzhen AOJ Medical Technology Co., Ltd.20180—