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510(k) Data Aggregation

    K Number
    K223740
    Device Name
    Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5)
    Manufacturer
    Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
    Date Cleared
    2023-10-05

    (295 days)

    Product Code
    CAW
    Regulation Number
    868.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Jiangsu Konsung Bio-Medical Science **And Technology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oxygen Concentrator is intended to be used by patients with require supplemental oxygen. The device can be used in home, institution environments. The device is not intended to sustain or support life. The device is intended for use in adults.
    Device Description
    Not Found
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    K Number
    K152091
    Device Name
    Fingertip Pulse Oximeter
    Manufacturer
    Jiangsu Konsung Bio-Medical Science & Technology Co. Ltd
    Date Cleared
    2016-08-18

    (388 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Jiangsu Konsung Bio-Medical Science **& Technology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fingertip Pulse Oximeter is intended for spot checking in measuring and displaying functional arterial hemoglobin (SpO2) and pulse rate of adult and pediatic patients in hospitals, hospital facilities and home healthcare environments.
    Device Description
    This device is a small, lightweight, portable device intended for use in measuring and displaying functional oxygen saturation of arterial haemoglobin (%SpO2) and pulse rate (PR).The device measures SpO2 and PR with a SpO2 senor and displays on the OLED after certain futher processing. The device is mainly composed of the motherboard, SpO2 transducer and built-in battery.
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    K Number
    K152089
    Device Name
    Wrist Pulse Oximeter
    Manufacturer
    Jiangsu Konsung Bio-Medical Science & Technology Co. Ltd
    Date Cleared
    2016-08-17

    (387 days)

    Product Code
    DQA, DOA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Jiangsu Konsung Bio-Medical Science **& Technology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wrist Pulse Oximeter is intended for spot checking in measuring and displaying oxygen saturation of functional arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients in hospital facilities and home healthcare environments.
    Device Description
    This device is a small, lightweight, portable device intended for use in measuring and displaying oxygen saturation of functional arterial haemoglobin (%SpO2) and pulse rate (PR).The device measures SpO2 and PR with a SpO2 senror and displays on the OLED after certain further processing. The device is mainly composed of the motherboard, SpO2 transducer and built-in battery. The power supply is 4.2V Li-battery and also the subject device can be powered by adapter. The subject device has a detachable sensor as an accessory to measure the SpO2 and pulse rate (PR). The subject device is not for life-supporting or life-sustaining and it is not an implantable device. The subject device owns software which has been validated by the manufacturer.
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