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510(k) Data Aggregation

    K Number
    K151415
    Device Name
    Oregon Scientific
    Date Cleared
    2015-10-21

    (147 days)

    Product Code
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    IDT TECHNOLOGY LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K131245
    Device Name
    OREGON SCINTIFIC
    Date Cleared
    2014-01-17

    (261 days)

    Product Code
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    IDT TECHNOLOGY LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    By using oscillometric method, the device measure automatically human's Systolic, Diastolic, mean blood pressure, and heart rate. This device is intended for use on adults for age 18 and above. The cuff size is fit for arm circumference of 22-32 cm. The device has the irregular heartbeat indicator feature. The color bar gives a warning signal with readings. The BPU321 can be compatible with the device of Bluetooth Smart-enabled. All values will be read out in LCD panel.
    Device Description
    Not Found
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    K Number
    K050083
    Device Name
    BLOOD-PRESSURE METER, BPW120
    Date Cleared
    2005-04-08

    (85 days)

    Product Code
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    IDT TECHNOLOGY LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    By using oscillometric method, measures automatically human's Systolic, Diastolic, mean blood pressure, and heart rate. All values will be read out in LCD panel.
    Device Description
    Blood-pressure meter, Model BPW120
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    K Number
    K031167
    Device Name
    HIGH PRECISION BODY WEIGHT MONITOR WITH BODY FAT INDEX
    Date Cleared
    2004-01-28

    (289 days)

    Product Code
    Regulation Number
    870.2770
    Why did this record match?
    Applicant Name (Manufacturer) :

    IDT TECHNOLOGY LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device measures body weight, and impedance using Bioelectrical Impedance The uevice measures body worgin, and cally fat percentage, BMI, with results displayed in LCD panel. The intended use of this device is for 7 to 99 years old normal subjects and not for I he intended use of ans econmended personal with implanted internal device like pacemaker or pregnant women to use this device.
    Device Description
    The device measures body weight, and impedance using Bioelectrical Impedance The uevice measures body worgin, and cally fat percentage, BMI, with results displayed in LCD panel.
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    K Number
    K020433
    Device Name
    FT101 FOREHEAD THERMOMETER; FT101 INFRARED DIGITAL THERMOMETER
    Date Cleared
    2002-07-11

    (153 days)

    Product Code
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    IDT TECHNOLOGY LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The FT101 Forehead Thermometer is an over-the-counter, non-sterile, reusable, infrared clinical electronic thermometer intended for the intermittent measurement and assessment of the skin forehead temperature of humans of all age ranges. The measured temperature correlates to axillary temperature.
    Device Description
    The FT101 Forehead Thermometer is an over-the-counter, non-sterile, reusable, nonpredictive clinical electronic thermometer designed to measure and assess the temperature of humans of all age ranges using an infrared detector to detect heat emission from the forehead. The measured temperature correlates to axillary temperature, and is displayed on a built-in LCD display. Calendar/clock functions are provided, and a memory function stores up to 10 temperature readings. The temperature reading range is 34 °C – 42.2 °C (92.3 F to 108.0 F), and the time of measurement is approximately 2 seconds, with a recommended cycle time of at least 30 seconds between readings. The unit operates in an ambient temperature range of 16 C – 35 C (61 F to 95 F). The FT101 Forehead Thermometer is entirely self-contained within one housing, and is battery-powered. The device is compact in size and weight, easy to use, portable and may be used in a variety of home or clinical settings.
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    K Number
    K021252
    Device Name
    BLOOD-PRESSURE METER
    Date Cleared
    2002-06-17

    (59 days)

    Product Code
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    IDT TECHNOLOGY LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    By using oscillometric method, measures automatically human's Systolic, Diastolic, mean blood pressure, and heart rate. All values will be read out in LCD panel.
    Device Description
    Blood-pressure meter, Model BPW128
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