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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., Ltd.

    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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