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

    OLYMPUS KC-10 MOBILE DISINFEC-STAT

    K Number: K841331 · Decision Jul 19, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    10
    Applicant Total
    29
    Review Days
    108

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    Basic Information

    Device Name
    OLYMPUS KC-10 MOBILE DISINFEC-STAT
    K Number
    K841331
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Keymed, Inc.
    Date Received
    April 2, 1984
    Decision Date
    July 19, 1984
    Product Code
    NZA
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NZA Accessories, Germicide, Cleaning, For Endoscopes

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