BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM

    K Number: K133989 · Decision Nov 25, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    51
    Review Days
    334

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    Basic Information

    Device Name
    AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM
    K Number
    K133989
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mortara Instrument, Inc.
    Date Received
    December 26, 2013
    Decision Date
    November 25, 2014
    Product Code
    DXN
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DXN System, Measurement, Blood-Pressure, Non-Invasive

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