BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇮🇱 Israel

    BINGO PRO

    K Number: K111474 · Decision Nov 2, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    45
    Applicant Total
    2
    Review Days
    159

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    Basic Information

    Device Name
    BINGO PRO
    K Number
    K111474
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Forum Engineering Technologies (96) , Ltd.
    Date Received
    May 27, 2011
    Decision Date
    November 2, 2011
    Product Code
    LQY
    Advisory Committee
    Unknown
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LQY Locator, Root Apex

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    Other Clearances by Forum Engineering Technologies (96) , Ltd.

    K Number Device Name
    K232551 EM-07 Cordless Endo Motor