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

    NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269

    K Number: K043436 · Decision Mar 17, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    11
    Applicant Total
    51
    Review Days
    94

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    Basic Information

    Device Name
    NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269
    K Number
    K043436
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nxstage Medical, Inc.
    Date Received
    December 13, 2004
    Decision Date
    March 17, 2005
    Product Code
    FKR
    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
    FKR Subsystem, Proportioning

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