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

    MODEL 6500 MERCURY ARC LIGHT SOURCE

    K Number: K896008 · Decision Dec 27, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    12
    Applicant Total
    18
    Review Days
    75

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    Basic Information

    Device Name
    MODEL 6500 MERCURY ARC LIGHT SOURCE
    K Number
    K896008
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Medical Dynamics, Inc.
    Date Received
    October 13, 1989
    Decision Date
    December 27, 1989
    Product Code
    GCP
    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
    GCP Endoscope, Ac-Powered And Accessories

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