BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇩🇪 Germany

    ARRIPRO 35 ST/TV

    K Number: K973115 · Decision Sep 2, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    17
    Applicant Total
    2
    Review Days
    13

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    Basic Information

    Device Name
    ARRIPRO 35 ST/TV
    K Number
    K973115
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1890
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arnold & Richter Cine Technik
    Date Received
    August 20, 1997
    Decision Date
    September 2, 1997
    Product Code
    IXC
    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
    IXC Illuminator, Radiographic-Film

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