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

    PHYSOFT AMS

    K Number: K130579 · Decision Dec 19, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    17
    Applicant Total
    1
    Review Days
    289

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    Basic Information

    Device Name
    PHYSOFT AMS
    K Number
    K130579
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Physicians Software Systems, LLC
    Date Received
    March 5, 2013
    Decision Date
    December 19, 2013
    Product Code
    MQS
    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
    MQS System, Hemodialysis, Access Recirculation Monitoring

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