FDA.reportPublic FDA data

510(k) K232893

Device
Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)
Applicant
Contec Medical Systems Co.,Ltd
510(k) number
K232893
Product code
KNG
Decision
Substantially Equivalent (SESE)
Decision date
2024-06-14
Date received
2023-09-18
Regulation
884.2660
Classification name
Monitor, Ultrasonic, Fetal
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jie Xiao
Address
#112 Qinhuang W. St. Economic & Technical Development Zone Qinhuangdao CN 066004 066004

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KNG#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252669Fetal Doppler U8-25, U9-25Zhongshan Xiaolan Town Senlan Electronic Factory2026-01-08
K242846Doppler FHR Detector (BF-500D+, BF-560)Shenzhen Bestman Instrument Co., Ltd.2025-06-26
K233823Ultrasonic Fetal DopplerShenzhen Jamr Technology Co., Ltd.2024-06-28
K220245Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)Contec Medical Systems Co.,Ltd2022-09-28
K211940Fetal DopplerShenzhen Taikang Medical Equipment Co., Ltd.2022-01-07
K212084Fetal DopplerShenzhen Mericonn Technology Co., Ltd.2021-11-03
K191110HeraBEAT™ USHeramed, Ltd.2019-11-14
K182526Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D)Vcomin Technology Limited2019-05-29
K182710Fetal Doppler, Model FD88Shenzzhen Luckcome Technology Inc., Ltd.2019-03-01
K182190Fetal DopplerShenzhen AOJ Medical Technology Co., Ltd.2018-12-19
K180419Ultrasonic Doppler (Model YM-2T8)Shenzhen Imdk Medical Technology Co., Ltd.2018-07-19
K172780SD1 Ultrasonic Pocket DopplerEdan Instruments, Inc.2018-06-06
K153475SD5 & SD6 Ultrasonic Tabletop DopplerEdan Instruments, Inc.2016-01-29
K140579ULTRASONIC POCKET DOPPLEREdan Instruments, Inc.2015-02-06
K131457FETAL ULTRASONIC MONITOR AND ACCESSORIESShenzhen Jumper Medical Equipment Co., Ltd.2014-01-24