FDA 510(k) Applications Submitted by Bistos Co., Ltd.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K052190 |
08/11/2005 |
FETAL MONITOR, MODELS BT-300 AND BT-200 |
BISTOS CO., LTD. |
| K210289 |
02/02/2021 |
Infant Phototherapy Equipment |
Bistos Co., Ltd. |
| K232991 |
09/22/2023 |
BT-1000 |
Bistos Co., Ltd. |
| K200675 |
03/16/2020 |
Hi bebe super (Models BT-150S and BT-150L) |
Bistos Co., Ltd. |
| K160274 |
02/02/2016 |
Hi bebe plus |
BISTOS CO., LTD. |
| K103545 |
12/02/2010 |
BT-350 |
BISTOS CO., LTD. |
| K100885 |
03/30/2010 |
FETAL MONITOR MODEL: BT-200T |
BISTOS CO., LTD. |
| K121267 |
04/26/2012 |
BT-200V VASCULAR DOPPLER |
BISTOS CO., LTD. |
| K132543 |
08/13/2013 |
INFANT INCUBATOR |
BISTOS CO., LTD. |
| K142799 |
09/29/2014 |
Model BT-220L and BT-220C |
Bistos Co., Ltd. |
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