Medical Device Manufacturer · US , Flintville , TN

Bistos Co., Ltd.

11 submissions · 11 cleared · Since 2005
11
Total
11
Cleared
0
Denied

Bistos Co., Ltd. — FDA 510(k) Submissions

Bistos Co., Ltd. has submitted 11 FDA 510(k) premarket notifications since 2005, of which 11 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Monitoring, Perinatal, Pump, Breast, Powered, Incubator, Neonatal, Unit, Neonatal Phototherapy, Transcutaneous Nerve Stimulator For Adhd . Use the specialty filter in the sidebar to narrow results.

11 devices
1–11 of 11
Hi bebe super (BT-150B)
K251512 · HGX Pump, Breast, Powered · Obstetrics & Gynecology
Sep 2025 132d
BT-1000
K232991 · QGL Transcutaneous Nerve... · Neurology
Aug 2024 341d
Infant Phototherapy Equipment
K210289 · LBI Unit, Neonatal Phototherapy · General Hospital
May 2021 115d
Hi bebe super (Models BT-150S and BT-150L)
K200675 · HGX Pump, Breast, Powered · Obstetrics & Gynecology
Feb 2021 331d
Hi bebe plus
K160274 · HGX Pump, Breast, Powered · Obstetrics & Gynecology
Sep 2016 212d
Model BT-220L and BT-220C
K142799 · HGM System, Monitoring,... · Obstetrics & Gynecology
Jul 2015 283d
INFANT INCUBATOR
K132543 · FMZ Incubator, Neonatal · General Hospital
Jul 2014 324d
BT-200V VASCULAR DOPPLER
K121267 · HGM System, Monitoring,... · Radiology
Aug 2012 98d
BT-350
K103545 · HGM System, Monitoring,... · Obstetrics & Gynecology
May 2011 162d
FETAL MONITOR MODEL: BT-200T
K100885 · HGM System, Monitoring,... · Radiology
Jun 2010 69d
FETAL MONITOR, MODELS BT-300 AND BT-200
K052190 · HGM System, Monitoring,... · Obstetrics & Gynecology
Oct 2005 54d
Filters