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

    MEDI-KLEER

    K Number: K904871 · Decision Sep 17, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    26
    Applicant Total
    1
    Review Days
    323

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    Basic Information

    Device Name
    MEDI-KLEER
    K Number
    K904871
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    North American Marketing Corp.
    Date Received
    October 29, 1990
    Decision Date
    September 17, 1991
    Product Code
    OCT
    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
    OCT Anti Fog Solution And Accessories, Endoscopy

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