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Bistos Co., Ltd.

FDA 510(k) & PMA Approved Devices — 9 products

Total Devices9
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K251512 Hi bebe super (BT-150B)HGX2025-09-25 View
510(k) K232991 BT-1000QGL2024-08-28 View
510(k) K210289 Infant Phototherapy EquipmentLBI2021-05-28 View
510(k) K200675 Hi bebe super (Models BT-150S and BT-150L)HGX2021-02-10 View
510(k) K160274 Hi bebe plusHGX2016-09-01 View
510(k) K121267 BT-200V VASCULAR DOPPLERHGM2012-08-02 View
510(k) K103545 BT-350HGM2011-05-13 View
510(k) K100885 FETAL MONITOR MODEL: BT-200THGM2010-06-07 View
510(k) K052190 FETAL MONITOR, MODELS BT-300 AND BT-200HGM2005-10-04 View
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