BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    OES ELITE Telescopes, Protective Tube

    K Number: K151191 · Decision Nov 24, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    4
    Applicant Total
    43
    Review Days
    204

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    Basic Information

    Device Name
    OES ELITE Telescopes, Protective Tube
    K Number
    K151191
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Olympus Winter & Ibe GmbH
    Date Received
    May 4, 2015
    Decision Date
    November 24, 2015
    Product Code
    FBP
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FBP Telescope, Rigid, Endoscopic

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