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

    FIBER OPTIC ENDOILLUMINATION PROBE

    K Number: K980636 · Decision May 20, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    25
    Applicant Total
    10
    Review Days
    90

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    Basic Information

    Device Name
    FIBER OPTIC ENDOILLUMINATION PROBE
    K Number
    K980636
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dutch Ophthalmic USA, Inc.
    Date Received
    February 19, 1998
    Decision Date
    May 20, 1998
    Product Code
    FFS
    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
    FFS Image, Illumination, Fiberoptic, For Endoscope

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