Bistos Co., Ltd.
FDA 510(k) & PMA Approved Devices — 5 products
Total Devices5
Categories3
Latest FDA decision2025-09-25
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K251512 | Hi bebe super (BT-150B) | HGX | 2025-09-25 | View |
| 510(k) | K232991 | BT-1000 | QGL | 2024-08-28 | View |
| 510(k) | K210289 | Infant Phototherapy Equipment | LBI | 2021-05-28 | View |
| 510(k) | K200675 | Hi bebe super (Models BT-150S and BT-150L) | HGX | 2021-02-10 | View |
| 510(k) | K160274 | Hi bebe plus | HGX | 2016-09-01 | View |
No matching devices.