Bistos Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251512Hi bebe super (BT-150B)September 25, 2025
K232991BT-1000August 28, 2024
K210289Infant Phototherapy EquipmentMay 28, 2021
K200675Hi bebe super (Models BT-150S and BT-150L)February 10, 2021
K160274Hi bebe plusSeptember 1, 2016
K142799Model BT-220L and BT-220CJuly 9, 2015
K132543INFANT INCUBATORJuly 3, 2014
K121267BT-200V VASCULAR DOPPLERAugust 2, 2012
K103545BT-350May 13, 2011
K100885FETAL MONITOR MODEL: BT-200TJune 7, 2010
K052190FETAL MONITOR, MODELS BT-300 AND BT-200October 4, 2005