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510(k) Data Aggregation

    K Number
    K080274
    Device Name
    AMBULO 2400
    Manufacturer
    TIBA MEDICAL, INC.
    Date Cleared
    2008-04-23

    (82 days)

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

    TIBA MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ambulo 2400 Ambulatory Blood Pressure Monitor is designed to measure systolic and diastolic blood pressure and pulse rate of adults who are eighteen (18) years and older, using the oscillometric method on a cuffed arm.
    Device Description
    The Ambulo 2400 is a compact, lightweight, non-invasive ambulatory blood monitoring system. The Ambulo 2400 can measure systolic and diastolic blood pressure, mean arterial pressure and pulse rate over a 24 hour period. It is easily configured and individually-fitted for each patient by a physician or health care professional. Measurements are automatically captured, without medical supervision, by the Ambulo 2400 and later downloaded to a computer for analysis and interpretation by a physician.
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