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

    Amia Automated PD System with Sharesource

    K Number: K151525 · Decision Oct 9, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    82
    Applicant Total
    13
    Review Days
    123

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    Basic Information

    Device Name
    Amia Automated PD System with Sharesource
    K Number
    K151525
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Deka Research and Development
    Date Received
    June 8, 2015
    Decision Date
    October 9, 2015
    Product Code
    FKX
    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
    FKX System, Peritoneal, Automatic Delivery

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