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

    MODEL 600 VASCULAR DUPLEX IMAGER

    K Number: K863589 · Decision Jun 24, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    77
    Applicant Total
    8
    Review Days
    282

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    Basic Information

    Device Name
    MODEL 600 VASCULAR DUPLEX IMAGER
    K Number
    K863589
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Multigon Industries, Inc.
    Date Received
    September 15, 1986
    Decision Date
    June 24, 1987
    Product Code
    DXK
    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
    DXK Echocardiograph

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