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

    NXSTAGE SYSTEM ONE

    K Number: K030470 · Decision Jul 7, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    51
    Review Days
    145

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    Basic Information

    Device Name
    NXSTAGE SYSTEM ONE
    K Number
    K030470
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5860
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nxstage Medical, Inc.
    Date Received
    February 12, 2003
    Decision Date
    July 7, 2003
    Product Code
    FII
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    FII System, Dialysate Delivery, Sealed

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