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

    R.L. MEDICAL TWIN LIGHT SOURCE

    K Number: K842609 · Decision Aug 9, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    30
    Applicant Total
    7
    Review Days
    35

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    Basic Information

    Device Name
    R.L. MEDICAL TWIN LIGHT SOURCE
    K Number
    K842609
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Tridak Division of Indicon, Inc.
    Date Received
    July 5, 1984
    Decision Date
    August 9, 1984
    Product Code
    FCW
    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
    FCW Light Source, Fiberoptic, Routine

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