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510(k) Data Aggregation

    K Number
    K181089
    Device Name
    SureLead Cable System
    Manufacturer
    Date Cleared
    2020-01-17

    (632 days)

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

    Authentic Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SureLead Disposable Cable System is intended to be used with ECG monitoring devices. The SureLead Disposable Cable System is used to connect electrodes, catheters, and/or sensors placed at appropriate sites on the patient to a monitoring device for generating monitoring and/or diagnostic evaluation by a health care professional.
    Device Description
    The SureLead Disposable Cable System with specific various lengths are the replacements for similar cables manufactured by Original Equipment Manufacturers (OEM) and other third-party after-market manufacturers for their respective monitors. These cables consist of connectors on each cable end and a shielded bulk cable. These cables are used to transfer the signals from the electrodes to the patient monitor. The SureLead Disposable Cable System uses the same type of construction and have the same technological characteristics as the predicate device. The SureLead Disposable Cable System is made of medical grade PVC and PP cable jacket with medical grade PVC and PP over molded connectors with integral relief.
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