Contec Medical Systems Co.,Ltd

Medical device manufacturer in Qinhuangdao, Chin.

12510(k) clearances
0PMA approvals
1recalls

Device types

510(k) clearances

510(k)DeviceDecision
K232893Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal…KNG · Traditional 06/14/2024SE
K232895B-Ultrasound Diagnostic SystemIYO · Traditional 05/03/2024SE
K232908Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound…IYN · Traditional 05/02/2024SE
K220245Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)KNG · Traditional 09/28/2022SE
K202757CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50…DXN · Traditional 04/28/2021SE
K201980Infrared ThermometerFLL · Traditional 12/18/2020SE
K171360CONTEC™ ElectrocardiographDPS · Traditional 01/22/2018SE
K170856CMS600P2 B-Ultrasound Diagnostic SystemIYO · Traditional 11/17/2017SE
K170954Portable ECG MonitorDPS · Traditional 05/30/2017SE
K152863Portable ECG MonitorDPS · Traditional 06/22/2016SE
K141362Pulse Oximeter CMS50EWDQA · Traditional 04/23/2015SE
K110775Electronic SphygmomanometerDXN · Traditional 05/13/2011SE

Recalls

RecallProductInitiated
Z-1764-2025 Class IICMS8000 Patient MonitorPatient monitor has nine identified cybersecurity vulnerabilities. 04/10/2025Open, Classified