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510(k) Data Aggregation

    K Number
    K212008
    Device Name
    Reveal LINQ Insertable Cardiac Monitor
    Manufacturer
    Medtronic. Inc.
    Date Cleared
    2021-07-22

    (24 days)

    Product Code
    MXD
    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
    Device Description
    The Reveal LINQ Model LNQ11 Insertable Cardiac Monitors (ICM) is designed to automatically record the occurrence of arrhythmias in a patient. Arrhythmia may be classified as atrial tachyarrhythmia/atrial fibrillation (AT/AF), bradyarrhythmia, pause, or (fast) ventricular tachyarrhythmia. The Reveal LINQ ICM provides storage of ECG and Marker Channel during patient-activated and automatically-detected (auto-activated) events. Auto activation may help to detect abnormal heart rhythms in patients who may not activate/trigger the ICM. The Reveal LINO ICM Model LNO11 is a small. leadless device that is typically implanted under the skin, in the chest. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG.
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