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510(k) Data Aggregation

    K Number
    K062811
    Device Name
    DPILOG, MODEL DPC-512
    Date Cleared
    2006-12-20

    (92 days)

    Product Code
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIFE OUTCOMES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DPILog is intended for use by a single patient under the care or treatment of a physician or licensed healthcare professional. The DPILog is prescribed by the doctor when detailed Dry Powder Inhaler (DPI) usage monitoring is indicated. The DPILog can be used by any patient who regularly uses DPIs as prescribed by a physician.
    Device Description
    The DPILog DPC-512 is comprised of a reusable electronics module and a disposable battery sleeve that snaps together around an already cleared/marketed dry power inhaler. The device utilizes previously cleared/marketed accessories, i.e., an infrared docking station to communicate the collected data to a computer via an interface cable and software. The DPILog System has direct application to physicians involved in clinical trial disease management and training patients in proper use of DPIs. The objective data collected by the DPILog allows researchers improved quality of information in clinical trials and increased precision of statistical analysis.
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