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    K Number
    K163460
    Device Name
    Reveal LINQ Insertable Cardiac Monitor
    Manufacturer
    MEDTRONIC,INC.
    Date Cleared
    2017-02-14

    (67 days)

    Product Code
    MXD, DSI
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reveal LINQ ICM is an insertable automatically-activated monitoring system that records subcutaneous ECG and is indicated in the following cases: · patients with clinical syndromes or situations at increased risk of cardiac arrhythmias · patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia The device has not been tested specifically for pediatric use.
    Device Description
    The Reveal LINQ ICM (Model LNQ11) in association with the LINQ Mobile Manager Application (Model MSW001 or MSW002) and patient connector (Model 24965 and 24967) (referred to as the LINQ Mobile Manager system) are substantially equivalent to the following predicate device: Reveal LINQ ICM (Model LNO11) cleared via K160689 on April 22, 2016.
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