Bistos Co., Ltd.

Address:116~122ho, Jungang Induspia 3, 27, Sagimakgol-ro 105beon-gil,Seongnam Gyeonggi,KR

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Monitoring, Perinatal (HGM) (9) Unit, Neonatal Phototherapy (LBI) (1)

Premarket Exempt

No Yes

Clear

Hi-dop - 00887529000014 Catalog Number : OSD-14200V-001

Device Description : Bistos' BT-200V is a pocket size Ultrasound Doppler System, 2 MHz Ultrasound Dop

Device Class :

Duns Number: 689908411

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Hi-bebe - 00887529000021 Catalog Number : MKT-200-1501

Device Description : BT-200 is a pocket-size fetal Monitor that measures the fetal heat rate and outp

Device Class :

Duns Number: 689908411

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Hi-bebe - 00887529000038 Catalog Number : MKT-200-1501

Device Description : BT-200 is a pocket-size fetal Monitor that measures the fetal heat rate and outp

Device Class :

Duns Number: 689908411

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

N/A - 00887529000045 Catalog Number : MKT-200-1501

Device Description : Bistos’ BT-200T is a pocket size Fetal Doppler that measures the fetal heart rat

Device Class :

Duns Number: 689908411

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

N/A - 00887529000052 Catalog Number : MKT-350-1509

Device Description : BT-350 is the fetal monitor that measures the fetal heart rate(FHR) and uterine

Device Class :

Duns Number: 689908411

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

N/A - 00887529000069 Catalog Number : MKT-350-1509

Device Description : BT-350 is the fetal monitor that measures the fetal heart rate(FHR) and uterine

Device Class :

Duns Number: 689908411

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

N/A - 00887529000083 Catalog Number : OSD-14220-001

Device Description : Bistos’ BT-220L is a pocket size Fetal Doppler that measures the fetal heart rat

Device Class :

Duns Number: 689908411

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

N/A - 00887529000090 Catalog Number : OSD-14220-001

Device Description : Bistos’ BT-220C is a pocket size Fetal Doppler that measures the fetal heart rat

Device Class :

Duns Number: 689908411

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

N/A - 00887529000106 Catalog Number : OSD-15300-001

Device Description : BT-300 is the fetal monitor that measures the fetal heart rate(FHR) which may be

Device Class :

Duns Number: 689908411

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

N/A - 00887529000113 Catalog Number : MKT-400-1510

Device Description : BT-400 Neonatal phototherapy is designed to emit the blue light wave length rang

Device Class :

Duns Number: 689908411

Premarket Exempt : No

Product Code : LBI

Prescription Use : Yes

Device Count : 1

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