Contec Medical Systems Co., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 12
- Inspections
- 4
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1764-2025 | Class II | CMS8000 Patient Monitor | April 10, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K232893 | Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 1 | June 14, 2024 |
| K232895 | B-Ultrasound Diagnostic System | May 3, 2024 |
| K232908 | Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (C | May 2, 2024 |
| K220245 | Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) | September 28, 2022 |
| K202757 | CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood | April 28, 2021 |
| K201980 | Infrared Thermometer | December 18, 2020 |
| K171360 | CONTEC Electrocardiograph | January 22, 2018 |
| K170856 | CMS600P2 B-Ultrasound Diagnostic System | November 17, 2017 |
| K170954 | Portable ECG Monitor | May 30, 2017 |
| K152863 | Portable ECG Monitor | June 22, 2016 |
| K141362 | PULSE OXIMETER CMS50EW | April 23, 2015 |
| K110775 | ELECTRONIC SPHYGMOMANOMETER | May 13, 2011 |