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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
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for a "Patient Cable" device, indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory requirements and the device's indications for use but does not include performance data, study designs, or ground truth establishment details.

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