BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES

    K Number: K130842 · Decision May 21, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    198
    Applicant Total
    104
    Review Days
    55

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    Basic Information

    Device Name
    ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES
    K Number
    K130842
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1600
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medical Systems Nederland B.V.
    Date Received
    March 27, 2013
    Decision Date
    May 21, 2013
    Product Code
    IZI
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    IZI System, X-Ray, Angiographic

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