Bistos Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Hi bebe super (BT-150B), BT-1000, Infant Phototherapy Equipment
11
Total
11
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bistos Co., Ltd. Obstetrics & Gynecology ✕
6 devices
Cleared
Sep 25, 2025
Hi bebe super (BT-150B)
Obstetrics & Gynecology
132d
Cleared
Feb 10, 2021
Hi bebe super (Models BT-150S and BT-150L)
Obstetrics & Gynecology
331d
Cleared
Sep 01, 2016
Hi bebe plus
Obstetrics & Gynecology
212d
Cleared
Jul 09, 2015
Model BT-220L and BT-220C
Obstetrics & Gynecology
283d
Cleared
May 13, 2011
BT-350
Obstetrics & Gynecology
162d
Cleared
Oct 04, 2005
FETAL MONITOR, MODELS BT-300 AND BT-200
Obstetrics & Gynecology
54d