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

    PAPILLION PROCTOSCOPE

    K Number: K914784 · Decision Jun 5, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    3
    Applicant Total
    9
    Review Days
    226

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    Basic Information

    Device Name
    PAPILLION PROCTOSCOPE
    K Number
    K914784
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5900
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Oldelft Corp. of America
    Date Received
    October 23, 1991
    Decision Date
    June 5, 1992
    Product Code
    KQA
    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
    KQA Device, Beam Limiting, X-Ray, Therapeutic

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