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510(k) Data Aggregation

    K Number
    K232991
    Device Name
    BT-1000
    Manufacturer
    Bistos Co., Ltd.
    Date Cleared
    2024-08-28

    (341 days)

    Product Code
    QGL, OGL
    Regulation Number
    882.5898
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bistos Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BT-1000 external Trigeminal Nerve Stimulation System is indicated for treatment of pediatric Attention Deficit Hyperactivity Disorder (ADHD) as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications. The device is to be used for patient treatment by prescription only and is intended to be used in the home under the supervision of a caregiver during periods of sleep.
    Device Description
    Electrical stimulator that alleviate the symptoms of Attention Deficit Hyperactivity Disorder (ADHD), a psychological mental disorder, by non-invasively stimulating cranial nerves with fine electrical stimulation using extracorporeal electrodes. The treatment protocol using the BT-1000 is administered each night while the patient is sleeping, for 7-9 hours. The device is designed to provide non-invasive electrical stimulation of the trigeminal nerve via an electrode placed on the forehead.
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    K Number
    K210289
    Device Name
    Infant Phototherapy Equipment
    Manufacturer
    Bistos Co., Ltd.
    Date Cleared
    2021-05-28

    (115 days)

    Product Code
    LBI
    Regulation Number
    880.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bistos Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BiliTouch™, model Motif Phototherapy Blanket and Infant Phototherapy Equipment, model BT-450 for use to treatment of infants diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a yellow discoloration of the skin and the whites of the eyes. The devices can be used in a hospital or at home. The device is designed to use for patient population described in the infant, who is age up to 3 months and weight less than 10 kg.
    Device Description
    Infant phototherapy equipment is a portable phototherapy light system delivers a narrow band of high-intensity blue light via blue light-emitting diodes (LEDs) to provide treatment for neonatal unconjugated hyperbilirubinemia. The device is comprised of a control box and pad including a disposable pad cover, rechargeable battery and AC/DC power supply. The pad is designed to provide phototherapy treatment from underneath the baby. Infant phototherapy equipment provides blue LEDs to achieve intensities by two-level with emitting light from blue LEDs (bandwidth 400 - 550 nm used). Treatment is intended to be applied until the bilirubin levels have dropped sufficiently that the child no longer suffers from jaundice. Phototherapy treatment of neonatal jaundice using the device can be applied at home or in a hospital.
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    K Number
    K200675
    Device Name
    Hi bebe super (Models BT-150S and BT-150L)
    Manufacturer
    Bistos Co., Ltd.
    Date Cleared
    2021-02-10

    (331 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bistos Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hi bebe super (Models BT-150S and BT-150L) is intended to be used by lactating women for expressing and collecting breast milk. It is intended for a single user.
    Device Description
    Hi bebe wer are powered breast pumps that are modified versions of the predicate device, K160274. The pumps are intended to express and collect milk from the breast of lactating women and are only to be used by a single user. The user has the option to pump breast milk from a single breast (single pumping) or from both breasts (double pumping). All patient-contacting and breast milk-contacting materials are identical to the predicate device. Hi bebesting includes two models, BT-150L and BT-150L includes a nursing lamp option, which is not available for BT-150S. Both models are comprised of a motor unit and accessories. The pumps are powered by rechargeable lithium ion batteries (7.4 V Li-ion polymer, 2200 mA) and are software-controlled. The Hi bebe®™ breast pumps have two operating modes: massage mode and expression mode. The subject device also includes backflow protection feature to prevent milk from contacting the pump during use. For accessories, a 32 mm size funnel is added in addition to 21/24/27 mm.
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    K Number
    K160274
    Device Name
    Hi bebe plus
    Manufacturer
    BISTOS CO., LTD.
    Date Cleared
    2016-09-01

    (212 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    BISTOS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hi bebeplus, model BT-100, electric breast pump is intended to be used by lactating women for expressing and collecting breast milk. It is intended for a single user.
    Device Description
    The Hi bebeplus, model BT-100, is an electrically powered, software-controlled breast pump intended to express and collect milk from the breast of lactating women. The breast pump system is comprised of a motor unit and pump kit including tubing.. The pump is intended to be used by a single user. The user has the option to pump breast milk from a single breast (single pumping) or from both breasts (double pumping). The Hi bebeplus, model BT-100 also includes back flow protection and it is powered by a 12V DC adaptor or rechargeable lithium battery. The Hi bebeplus, model BT-100 has two operating functions: basic massage/expression function and memory function to save the operating sequence. The Hi bebeplus, model BT-100, is capable of providing vacuum levels from 32-227 mmHg with cycling rates up to 63 cycles per minute.
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    K Number
    K142799
    Device Name
    Model BT-220L and BT-220C
    Manufacturer
    Bistos Co., Ltd.
    Date Cleared
    2015-07-09

    (283 days)

    Product Code
    HGM
    Regulation Number
    884.2740
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bistos Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BT-220L/220C is a pocket sized ultrasonic fetal monitor that measures heart rate, which is displayed on an LCD display, and outputs fetal heart sounds through a built in speaker. The fetal heart rate is measured using Doppler ultrasound.
    Device Description
    Bistos' BT-220L, BT-220C is a pocket size Fetal Doppler that measures the fetal heart rate and out put the fetal sound through built-in speaker. By measuring fetal heart rate (FHR), they are able to predict fetal well-being. BT-220 irradiates ultrasound 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.
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    K Number
    K132543
    Device Name
    INFANT INCUBATOR
    Manufacturer
    BISTOS CO., LTD.
    Date Cleared
    2014-07-03

    (324 days)

    Product Code
    FMZ
    Regulation Number
    880.5400
    Why did this record match?
    Applicant Name (Manufacturer) :

    BISTOS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bisto's BT-500 is a Infant Incubator and intended to keep Premature in a warm environment in the hood for Neonatal hypothermia, Observation and Examination in newborn nurseries. BT-500 provides Heat and Air in a controlled manner to neonates or premature infants who are unable to themn-regulate on their own physiology. BT-500 is not intended for transport.
    Device Description
    BT-500 Infant Incubator consists of Hood, Control Box, LCD external monitor and main body with stand ( optional), This device incorporates two sensors to control Humidity, and Temperature inside the Hood and monitors the Air Conditions, and controls Circulation with proper temperature. Also Heater is equipped inside of the hood to control the Skin Temperature of Infant at a fixed level as measured by the skin probe and showing, measuring and graphing the humidity, Air Temperature, Skin Temperature, Weight and SpO2 This Incubator is provided with function to control the infant's skin temperature.
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    K Number
    K121267
    Device Name
    BT-200V VASCULAR DOPPLER
    Manufacturer
    BISTOS CO., LTD.
    Date Cleared
    2012-08-02

    (98 days)

    Product Code
    HGM
    Regulation Number
    884.2740
    Why did this record match?
    Applicant Name (Manufacturer) :

    BISTOS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BT-200V Vascular Doppler ( Brand Hi-dop ) detects arterial and venous Hood flow in extremities as well as fetal heart sounds. and displays velocity waveform, numerical data and fetal heart rate with heart beat indicator. The BT-200V selection is 2, 4, 5 and 8 MHz.
    Device Description
    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. The following probes may be utilized with the BT-200V Vascular doppler: 2 MHz for fetal heart rate 4 MHz detections of arterial and venous blood flow velocity 5 MHz detections of arterial and venous blood flow velocity 8 MHz detections of arterial and venous blood flow velocity
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    K Number
    K103545
    Device Name
    BT-350
    Manufacturer
    BISTOS CO., LTD.
    Date Cleared
    2011-05-13

    (162 days)

    Product Code
    HGM
    Regulation Number
    884.2740
    Why did this record match?
    Applicant Name (Manufacturer) :

    BISTOS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BT-350 is a Prenatal Monitoring System for non-invasively measuring and showing graphically maternal abdominal contractions and the fetal heart rate by means of display on a non-permanent graphical display and on a strip chart recorder. This data is intended to aid in assessing the well being of the fetus during the antepatum periods(Non-Stress Test.) Therefore the Bt-350 is not used in delivery room. ,This device is for use only by trained medical personnel located in hospitals, clinics, doctor's offices and in the patient's home.
    Device Description
    BT-350 is the fetal monitor that measures the fetal heart rate(FHR) and uterine contraction. Using these parameters, the medical team can monitor fetal status and check uterine contraction degree. BT-350 irradiates ultrasound wave to the abdomen of a pregnant woman, and detects the Doppler frequency signal reflected from the heart of the fetus. BT-350 analyzes this signal and displays the heart rate by LCD or LED(7-Segment). Also, BT-350 provides the sound from the heart of fetus. BT-350 measures the uterine contraction of a pregnant woman by pressure sensors and displays the numerical values. And BT-350 prints the heart rate of the fetus and the values of uterine contraction. BT-350 records the heart rate of the fetus, the uterine contraction of a pregnant woman, and basic information of the equipment with a provided thermal printer. BT-350 is capable of Twin Monitoring with two pulsed Ultrasound Transducers. BT-350 has a free voltage(100 240VAC input) power adaptor.
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    K Number
    K100885
    Device Name
    FETAL MONITOR MODEL: BT-200T
    Manufacturer
    BISTOS CO., LTD.
    Date Cleared
    2010-06-07

    (69 days)

    Product Code
    HGM
    Regulation Number
    884.2740
    Why did this record match?
    Applicant Name (Manufacturer) :

    BISTOS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BT-200T is a Fetal Monitor for measuring Fetal Heart Rate, Data is displayed on a front panel LCD display, Fetal heart may be measured by means of Doppler ultrasound. BT-200T is pocket size Fetal Monitor for measuring Fetal Heart rate, Pulse Doppler and uterine contraction of pregnant women. It is intended to aid a comprehensive check for the well being of single fetus.
    Device Description
    Bistos' BT-200T is a pocket size Fetal Monitor that measures the fetal heart rate and out puts the fetal sound through built-in speaker. By measuring fetal heart rate (FHR), they are able to predict fetal well-being. BT-200T irradiates ultrasound 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.
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    K Number
    K052190
    Device Name
    FETAL MONITOR, MODELS BT-300 AND BT-200
    Manufacturer
    BISTOS CO., LTD.
    Date Cleared
    2005-10-04

    (54 days)

    Product Code
    HGM, HGL
    Regulation Number
    884.2740
    Why did this record match?
    Applicant Name (Manufacturer) :

    BISTOS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BT-300 is an Fetal Monitor for measuring and recording maternal contraction and fetal heart rate. Data is displayed on a front panel 7-segment LED Display, recorded on a strip chart recorder and may be transmitted over telephone lines to a remote data receiver. Single/Twin fetal heart rates may be measured by means of Doppler Ultrasound. Uterine Activity is measured with an external TOCO transducer. The BT200 is a Fetal Monitor for measuring fetal heart rate. Data is displayed on a front panel LCD Display. Fetal heart rate may be measured by means of Doppler Ultrasound.
    Device Description
    BT-300 is the fetal monitor that measures the fetal heart rate(FHR) which may be evaluated to predict fetal status and uterine contraction. BT-300 irradiates ultrasound wave to the abdomen of a pregnant woman, and detects the Doppler frequency signal reflected from the heart of the fetus. BT-300 analyzes this signal and displays the heart rate by LED. Also, BT-300 provides the sound from the heart of fetus. BT-300 measures the uterine contraction of a pregnant woman by pressure sensors and displays the numerical values. And BT-300 prints the heart rate of the fetus and the values of uterine contraction. BT-300 records the heart rate of the fetus, the uterine contraction of a pregnant woman, and basic information of the equipment with a provided thermal printer. BT-300 is capable of Twin Monitoring with two pulsed Ultrasound Transducers. BT-300 has a free voltage(100 240VAC input) power adaptor. BT-200 is a pocket-size fetal Monitor that measures the fetal heat rate and outputs the fetal heart sound through built-in speaker. By measuring fetal heart rate(FHR), you are able to predict fetal well-being. BT-200 irradiates fetal wave to the abdomen of a pregnant woman to detect the Doppler frequency signal and analyze, and displays the heart rate on LCD screen. The device also provides the heart sound from the heart of fetus.
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