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510(k) Data Aggregation

    K Number
    K070529
    Device Name
    AFF (MARK I) VOLUMETRIC INFUSION PUMP
    Date Cleared
    2007-05-08

    (74 days)

    Product Code
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEFINITIVE MEDICAL TECHNOLOGIES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AFF (MARK I) Volumetric Infusion Pump is indicated for delivering infusions of medications, as well as providing TPN (Total Parenteral Nutrition) and PCA (Patient Control Analgesia). It is intended for use in hospitals, ambulatory & nursing home (extended care) settings, and home care environments.
    Device Description
    The Definitive Medical Technologies AFF (Mark I) Volumetric Infusion Pump is a medical device used to pump fluids into a patient in a controlled manner. It is suitable for delivering a wide range of infusions, including medications, as well as providing TPN (Total Parenteral Nutrition) and PCA (Patient Control Analgesia) operating modes. It is also compatible with the majority of IV procedures and most standard IV sets.
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