BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    HEMORPEX SYSTEM

    K Number: K090432 · Decision May 29, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    26
    Applicant Total
    2
    Review Days
    99

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    Basic Information

    Device Name
    HEMORPEX SYSTEM
    K Number
    K090432
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Angiologica B. M. Srl
    Date Received
    February 19, 2009
    Decision Date
    May 29, 2009
    Product Code
    FER
    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
    FER Anoscope And Accessories

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