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

    APOLLO

    K Number: K050190 · Decision Mar 25, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    30
    Applicant Total
    13
    Review Days
    57

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    Basic Information

    Device Name
    APOLLO
    K Number
    K050190
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    892.1980
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Villa Sistemi Medicali S.P.A.
    Date Received
    January 27, 2005
    Decision Date
    March 25, 2005
    Product Code
    KXJ
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KXJ Table, Radiologic

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    K090749 ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191
    K080859 DRF 4343
    K030634 ENDOS DC
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