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

    ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565

    K Number: K042225 · Decision Sep 10, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    91
    Applicant Total
    16
    Review Days
    24

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    Basic Information

    Device Name
    ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565
    K Number
    K042225
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Acmi Corporation
    Date Received
    August 17, 2004
    Decision Date
    September 10, 2004
    Product Code
    FAJ
    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
    FAJ Cystoscope And Accessories, Flexible/Rigid

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