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510(k) Data Aggregation

    K Number
    K040562
    Device Name
    LIFECLINIC, MODEL 2400
    Manufacturer
    LIFECLINIC INTERNATIONAL, INC.
    Date Cleared
    2004-08-31

    (181 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIFECLINIC INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lifeclinic 2400 is intended to be used by the general public so that a user can measure his/her own blood pressure and pulse rate. It is not a diagnostic device, and only furnishes data so that users can consult their personal physicians. The Lifeclinic LC500 is indicated for the measurement of blood pressure and heart rate by members of the general public. The device does not perform any diagnoses; it only provides pressure and rate data to the users, who are advised to consult a physician.
    Device Description
    The Lifeclinic 2400 is an automated system for measuring blood pressure and pulse rate designed to be used by the general public in stores and other places. It is completely automatic, and measures blood pressure by the oscillometric method. The user is guided by a series of interactive screens and voice instructions. The Lifeclinic 2400 consists of a fixed cuff into which the user inserts an arm. The cuff automatically inflates and then deflates after the user presses a button. The device measures blood pressure using the oscillometric method.
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