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

    PENTAX Video Upper G.I. Scope EG34-i10

    K Number: K180292 · Decision Oct 12, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    74
    Applicant Total
    2
    Review Days
    253

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    Basic Information

    Device Name
    PENTAX Video Upper G.I. Scope EG34-i10
    K Number
    K180292
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pentax Medical of America, Inc.
    Date Received
    February 1, 2018
    Decision Date
    October 12, 2018
    Product Code
    FDS
    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
    FDS Gastroscope And Accessories, Flexible/Rigid

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    Other Clearances by Pentax Medical of America, Inc.

    K Number Device Name
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