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510(k) Data Aggregation

    K Number
    K211629
    Device Name
    Infrared forehead thermometer LD-FT-100B
    Date Cleared
    2021-12-08

    (195 days)

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

    Honsun (Nantong) Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The infrared forehead thermometer is a nonsterile, reusable clinical thermometer intended for measuring the human body temperature in non-contact mode on the center of the forehead as the measurement site on people of all ages except the age under the 1 year.
    Device Description
    The HONSUN infrared forehead thermometer is designed for measuring the body's temperature, is a handheld non-contact infrared thermometer, battery powered, detecting the infrared energy emitted in the forehead area within 0-3 cm (exclude 0 cm) that converts to a body temperature. The measurement site is center of the forehead, while reference body site is the oral. It is intended to measure the temperature of human body in home and hospital. lt consists of thermopile sensor, printed circuit board, enclosure, button and liquid crystal display. The pressure difference generated by the sensor after receiving the infrared signal is amplified and analyzed then displayed on the LCD screen in digital form. It will be automatically power off if left idle for 20 seconds.
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    K Number
    K132627
    Device Name
    AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
    Date Cleared
    2013-10-23

    (62 days)

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

    HONSUN (NANTONG) CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Fully Automatic Blood Pressure Monitor LD-535 & LD-539 is device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the arm.
    Device Description
    Fully Automatic Blood Pressure Monitor Model: LD-535 & LD-539
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    K Number
    K130925
    Device Name
    AUTOMATIC BLOOD PRESSURE MONITOR
    Date Cleared
    2013-09-12

    (162 days)

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

    HONSUN (NANTONG) CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K131463
    Device Name
    WRIST AUTOMATIC BLOOD PRESSURE MONITOR
    Date Cleared
    2013-07-08

    (48 days)

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

    HONSUN (NANTONG) CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Wrist Automatic Blood Pressure Monitor LD-737 is device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist.
    Device Description
    Wrist Automatic Blood Pressure Monitor Model: LD-737
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    K Number
    K092245
    Device Name
    ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE, MODEL LD-100
    Date Cleared
    2009-10-28

    (92 days)

    Product Code
    Regulation Number
    870.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    HONSUN (NANTONG) CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Aneroid Sphygmomanometer with Stethoscope is a non-automated, mechanical blood pressure monitor that is used for the indirect measurement (non-invasive) and display of arterial blood pressure. It can be used by professionals as well as trained individual users over age 18 at hospitals or at home. The device is for use in OTC.
    Device Description
    The Aneroid Sphygmomanometer with Stethoscope is a non-invasive blood pressure monitor that uses an occluding cuff, an aneroid Sphygmomanometer to measure pressure and a stethoscope for detecting Korotkoff sounds. The Aneroid Sphygmomanometer with Stethoscope contains: 1. Adjustable D-ring Cuff (Adult Size) 2. Stethoscope (Attaches to the cuff) 3. Non-stop rotary pin, 300 mmHg gauge 4. Instruction booklet and record 5. Carrying case.
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