Bistos Co., Ltd.
Medical device manufacturer in Seongnam-Si, KR.
11510(k) clearances
0PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K251512 | Hi bebe super (BT-150B)HGX · Special | 09/25/2025SE |
| K232991 | BT-1000QGL · Traditional | 08/28/2024SE |
| K210289 | Infant Phototherapy EquipmentLBI · Traditional | 05/28/2021SE |
| K200675 | Hi bebe super (Models BT-150S and BT-150L)HGX · Special | 02/10/2021SE |
| K160274 | Hi bebe plusHGX · Traditional | 09/01/2016SE |
| K142799 | Model BT-220L and BT-220CHGM · Traditional | 07/09/2015SE |
| K132543 | Infant IncubatorFMZ · Traditional | 07/03/2014SE |
| K121267 | BT-200V Vascular DopplerHGM · Traditional | 08/02/2012SE |
| K103545 | BT-350HGM · Traditional | 05/13/2011SE |
| K100885 | Fetal Monitor Model: BT-200THGM · Traditional | 06/07/2010SE |
| K052190 | Fetal Monitor, Models BT-300 and BT-200HGM · Traditional | 10/04/2005SE |