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510(k) Data Aggregation

    K Number
    K061115
    Device Name
    SPEEDFLOW 0.2UM FILTER, MODEL 11214; SPEEDFLOW 1.2UM FILTER, MODEL 11215; EASYDROP CONTROLLER, MODEL 11216
    Manufacturer
    GVS SPA
    Date Cleared
    2006-06-30

    (70 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    GVS SPA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated as a single use, sterile device for use in I.V. therapy when an extended fluid path is required for administration. Environment of use: Hospital, Emergency Medical Services settings, wherever I.V. fluid administration may be indicated.
    Device Description
    The GVS Speedflow I.V. Administration Set with Easydrop Flow Regulator consists of a tubing set with a 0.2um or a 1.2um filter, various connectors and accessories and an Easydrop flow regulator and is used as a fluid pathway for I.V. administration. A choice can be made on the volume of fluid by easily adjusting the drops/cc setting on the Easydrop Flow Regulator. GVS will offer custom sets to meet customer requirements and specifications.
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