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510(k) Data Aggregation

    K Number
    K080112
    Device Name
    PATIENT CABLE
    Manufacturer
    MED-DYNE
    Date Cleared
    2008-06-20

    (156 days)

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

    MED-DYNE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The cables are used to transfer monitoring signals from a patient's electrodes, which are connected to leadwires, to a patient's monitor, resulting in no direct contact with the patient. While medical personnel observe the patient, information is received through the cables and is displayed on the monitor. This information can then be used by medical personnel to assess the patient and determine the proper course of medical action.
    Device Description
    Not Found
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