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

    MEDIFIX

    K Number: K813498 · Decision Jan 7, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    8
    Applicant Total
    41
    Review Days
    24

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    Basic Information

    Device Name
    MEDIFIX
    K Number
    K813498
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1140
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Burron Medical Products, Inc.
    Date Received
    December 14, 1981
    Decision Date
    January 7, 1982
    Product Code
    KRK
    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
    KRK Manometer, Blood-Pressure, Venous

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