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510(k) Data Aggregation

    K Number
    K063484
    Device Name
    PATIENT DATA HANDLER & DEVICES (PDH&D)
    Manufacturer
    INTERMED ADVISORS, INC.
    Date Cleared
    2006-12-22

    (35 days)

    Product Code
    DRG
    Regulation Number
    870.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERMED ADVISORS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PDH&D is indicated for use in non-clinical settings to collect and transmit historical patient data to healthcare professionals to help support effective management of their patients.
    Device Description
    The PDH&D includes the Patient Data Handler (PDH) and peripheral biometric devices for the monitoring of chronic diseases. It is intended to be used as a communication tool, enabling Healthcare Providers and Care Managers to receive historical patient data including blood glucose levels, blood pressure, weight, peak flow volume, and oxygen saturation levels. Providers may review patient information over the InterMed Patient Provider Online Tool (IPPOT). The PDH&D is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgment.
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