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    K Number
    K201359
    Device Name
    ECG Cables and Leadwires
    Manufacturer
    Xinkang Medical Instrument Co., Ltd
    Date Cleared
    2020-10-01

    (133 days)

    Product Code
    DSA
    Regulation Number
    870.2900
    Why did this record match?
    Applicant Name (Manufacturer) :

    Xinkang Medical Instrument Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ECG Cables and Leadwires is intended to be used with ECG. The ECG Cables and Leadwires is used to connect electrodes placed at appropriate sites on the patient to ECG for general monitoring and/or diagnostic evaluation by health care professional.
    Device Description
    The ECG Cables and Leadwire is an external device used to transmit ECG signals from electrodes that are affixed to the patient's body for both diagnostic and monitoring purposes. One end of each leadwire is attached to ECG patient electrodes, the other end is affixed/molded into one end of the trunk cable which are plug into an ECG monitor.
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