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    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    DRF 4343

    K Number: K080859 · Decision Jun 4, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    299
    Applicant Total
    13
    Review Days
    69

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    Basic Information

    Device Name
    DRF 4343
    K Number
    K080859
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Villa Sistemi Medicali S.P.A.
    Date Received
    March 27, 2008
    Decision Date
    June 4, 2008
    Product Code
    JAA
    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
    JAA System, X-Ray, Fluoroscopic, Image-Intensified

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    Other Clearances by Villa Sistemi Medicali S.P.A.

    K Number Device Name
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    K130109 ENDOGRAPH DC
    K111152 ROTOGRAPH EVO 3D
    K090749 ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191
    K050190 APOLLO
    K030634 ENDOS DC
    K030185 ENDOS AC/ACP
    K002432 STRATO X
    K000412 VISION R/F TILTING TABLE
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