Contec Medical Systems Co.,Ltd FDA Approvals

0 new drug approvals and 5 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)510(k)Jun 14, 2024Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Jun 14, 2024
B-Ultrasound Diagnostic System510(k)May 3, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 3, 2024
Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C)510(k)May 2, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 2, 2024
Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)510(k)Sep 28, 2022Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Sep 28, 2022
CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor510(k)Apr 28, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Apr 28, 2021