Company · CN
Contec Medical Systems Co.,Ltd
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2024. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DPS | Electrocardiograph | 3 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 |
| KNG | Monitor, Ultrasonic, Fetal | 2 |
| DQA | Oximeter | 1 |
| FLL | Continuous Measurement Thermometer | 1 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 14, 2024 | K232893 | Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) Contec Medical Systems Co.,Ltd, CN | KNG |
| May 3, 2024 | K232895 | B-Ultrasound Diagnostic System Contec Medical Systems Co.,Ltd, CN | IYO |
| May 2, 2024 | K232908 | Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C) Contec Medical Systems Co.,Ltd, CN | IYN |
| Sep 28, 2022 | K220245 | Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) Contec Medical Systems Co.,Ltd, CN | KNG |
| Apr 28, 2021 | K202757 | CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor Contec Medical Systems Co.,Ltd, CN | DXN |
| Dec 18, 2020 | K201980 | Infrared Thermometer Contec Medical Systems Co.,Ltd, CN | FLL |
| Jan 22, 2018 | K171360 | CONTEC™ Electrocardiograph Contec Medical Systems Co.,Ltd, CN | DPS |
| Nov 17, 2017 | K170856 | CMS600P2 B-Ultrasound Diagnostic System Contec Medical Systems Co.,Ltd, CN | IYO |
| May 30, 2017 | K170954 | Portable ECG Monitor Contec Medical Systems Co.,Ltd, CN | DPS |
| Jun 22, 2016 | K152863 | Portable ECG Monitor Contec Medical Systems Co.,Ltd, CN | DPS |
| Apr 23, 2015 | K141362 | PULSE OXIMETER CMS50EW Contec Medical Systems Co.,Ltd, CN | DQA |
| May 13, 2011 | K110775 | ELECTRONIC SPHYGMOMANOMETER Contec Medical Systems Co.,Ltd, CN | DXN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 14, 2025 | Contec Medical Systems Co., Ltd. CMS8000 Patient Monitor Open, Classified |
MHX | K101692 |