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

    FRITCH OPHTHALMIC ENDOSCOPE

    K Number: K855151 · Decision Feb 19, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    55

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    Basic Information

    Device Name
    FRITCH OPHTHALMIC ENDOSCOPE
    K Number
    K855151
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Regtec
    Date Received
    December 26, 1985
    Decision Date
    February 19, 1986
    Product Code
    GDB
    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
    GDB Endoscope, Fiber Optic

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