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

    CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600

    K Number: K911384 · Decision Jun 25, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    77
    Applicant Total
    15
    Review Days
    89

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    Basic Information

    Device Name
    CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600
    K Number
    K911384
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Endosonics Corp.
    Date Received
    March 28, 1991
    Decision Date
    June 25, 1991
    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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