Seoul, KR · 4 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DPS | Electrocardiograph | Class II | Cardiovascular | 3 | 2023-12-15 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Class II | Radiology | 1 | 2022-10-11 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2023-12-15 | K231160 | Cardio Q50, Cardio Q70 | DPS | Class II | Cardiovascular |
| 2023-11-09 | K231150 | Cardio P1 | DPS | Class II | Cardiovascular |
| 2022-11-15 | K220535 | Cardio10 | DPS | Class II | Cardiovascular |
| 2022-10-11 | K220169 | SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25) | IYN | Class II | Radiology |