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510(k) Data Aggregation

    K Number
    K081471
    Device Name
    ECARD AND CCARD
    Manufacturer
    IRHYTHM TECHNOLOGIES, INC.
    Date Cleared
    2008-06-24

    (28 days)

    Product Code
    DXH
    Regulation Number
    870.2920
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The eCARD is a prescription only single patient use, event recording ECG monitor that can be worn for up to 30 days. It is indicated for use on patients who experience transient symptoms such as syncope, palpitations, shortness of breath, or chest pains.

    The cCARD is a prescription only single patient use, continuous recording ECG monitor that can be worn for up to 7 days. It is indicated for use on patients who experience transient symptoms such as syncope, palpitations, shortness of breath, or chest pains.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for the iRhythm Technologies eCARD and cCARD devices. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. The document is primarily a regulatory approval and lists the "Indications for Use" for the devices.

    Therefore, I cannot provide the requested information based on the given text.

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