Seongnam-Si, KR · 4 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| HGX | Pump, Breast, Powered | Class II | Obstetrics/Gynecology | 2 | 2025-09-25 |
| QGL | Transcutaneous Nerve Stimulator For Adhd | Class II | Neurology | 1 | 2024-08-28 |
| LBI | — | — | — | 1 | 2021-05-28 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-09-25 | K251512 | Hi bebe super (BT-150B) | HGX | Class II | Obstetrics/Gynecology |
| 2024-08-28 | K232991 | BT-1000 | QGL | Class II | Neurology |
| 2021-05-28 | K210289 | Infant Phototherapy Equipment | LBI | — | — |
| 2021-02-10 | K200675 | Hi bebe super (Models BT-150S and BT-150L) | HGX | Class II | Obstetrics/Gynecology |