Hi-dop - Bistos' BT-200V is a pocket size Ultrasound - Bistos Co., Ltd.

Duns Number:689908411

Device Description: Bistos' BT-200V is a pocket size Ultrasound Doppler System, 2 MHz Ultrasound Doppler Probe Bistos' BT-200V is a pocket size Ultrasound Doppler System, 2 MHz Ultrasound Doppler Probe that measure the fetal heart rate and outputs the Fetal Heart sound through built-in Speaker. By measuring fetal heart rate (FHR), they are able to predict fetal well-being.BT-200V irradiates fetal wave to the abdomen of a pregnant women to detect.The Doppler frequency signal and analyze, displays the heart rate in LCD screen.The device also provides the heart sound from the heart of fetus.4, 5, 8 MHz Ultrasound Doppler probe that measures the vascular pulse rate and outputs the blood flow sound through built-in speaker. By measuring pulse rate(PR) they are able to check vascular blood flow status.BT-200V irradiates vascular wave to the patient skin to detect the Doppler frequency signal and analyze to displays the pulse rate on LCD screen. The device also provides the blood flow sound from the patient.

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More Product Details

Catalog Number

OSD-14200V-001

Brand Name

Hi-dop

Version/Model Number

BT-200V

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K121267,K121267,K121267,K121267,K121267,K121267

Product Code Details

Product Code

HGM

Product Code Name

System, Monitoring, Perinatal

Device Record Status

Public Device Record Key

39299a8a-efad-4587-a71c-9ac6383c934a

Public Version Date

April 15, 2022

Public Version Number

5

DI Record Publish Date

June 14, 2016

Additional Identifiers

Package DI Number

30887529000015

Quantity per Package

10

Contains DI Package

10887529000011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton Box

"BISTOS CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 5