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

    HORIZON 2000 NON-INVASIVE BLOOD PRESSURE CAP.

    K Number: K854942 · Decision Jun 2, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    34
    Review Days
    174

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    Basic Information

    Device Name
    HORIZON 2000 NON-INVASIVE BLOOD PRESSURE CAP.
    K Number
    K854942
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Mennen Medical, Inc.
    Date Received
    December 10, 1985
    Decision Date
    June 2, 1986
    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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