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510(k) Data Aggregation

    K Number
    K023082
    Device Name
    BABYCARE
    Manufacturer
    BIONET COMPANY LTD
    Date Cleared
    2003-03-03

    (167 days)

    Product Code
    HEP
    Regulation Number
    884.2660
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIONET COMPANY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BABYCARE is a fetal ultrasonic monitor designed to transmit and receive ultrasonic energy into and from the pregnant woman by means of continuous wave (doppler) echoscopy. BABYCARE is a compact pocket Doppler, and it is intended for use to display the measured Fetal Heart Rate on LCD and to allow the user to hear a crystal clear Fetal Heart Beat Sound.
    Device Description
    BABYCARE is a fetal ultrasonic monitor designed to transmit and receive ultrasonic energy into and from the pregnant woman by means of continuous wave (doppler) echoscopy. BABYCARE is a compact pocket Doppler, and it is intended for use to display the measured Fetal Heart Rate on LCD and to allow the user to hear a crystal clear Fetal Heart Beat Sound. Being operated with battery, it allows babies to be checked anywhere, at any time. Using high sensitive and harmless ultrasound sensor, it detects and displays the accurate FHR on the LCD. BABYCARE is especially suitable for routine use in OB/GYN. Features: - Accurate FHR detection & display - - Clear sound offered from separate speaker - - Cap-shaped speaker for probe protection - - -Compact size and battery operated - Harmless ultrasound sensor " - Easy to use - Technical Specifications: - Display: 3-digit segment ー - FHR Measuring Range: 50-240 bpm - - Measurement Resolution: ± 3bpm - - Speaker output power: 1 W - - Ultrasound frequency: 2.0 Mhz - - Power: 9V batterv - - Sensitivity: 12 Weeks Fetus - - Weight: 290g (without battery) ~ - Standard Accessory: Gel, 9V battery --
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    K Number
    K023034
    Device Name
    CARDIOTOUCH-3000
    Manufacturer
    BIONET COMPANY LTD
    Date Cleared
    2002-11-14

    (63 days)

    Product Code
    LOS
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIONET COMPANY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CARDIOTOUCH-3000 is intended to be used under the direct supervision of a licensed healthcare practitioner. The CARDIOTOUCH-3000 is intended to be used by trained operators in a hospital or medical professional's facility environment to record ECG signals from surface electrodes. The device is intended to acquire, analyze, display, and record electrocardiographic information from adult population. The device is not intended for home use. The device is not designated for intracardial use.
    Device Description
    As an electrocardiograph with 12-channel, CARDIOTOUCH-3000 does not only provide parameters and diagnose a patient automatically for patient's electrocardiogram, but also it improves chart management by printing information on an operator as well as on the patient. Furthermore, for the convenience of operators, it is designed so that an operator needs to press a button once to let the machine measure and record patient's electrocardiogram, apply a filter, extract parameters, diagnose a patient automatically then print out a result on an A-4- size report. In addition, the built-in battery helps an operator carry and use CARDIOTOUCH-3000 easily and conveniently for a hospital on wheel and an emergency.
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    K Number
    K011328
    Device Name
    CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH
    Manufacturer
    BIONET COMPANY LTD
    Date Cleared
    2001-11-21

    (204 days)

    Product Code
    LOS
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIONET COMPANY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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