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510(k) Data Aggregation

    K Number
    K130951
    Device Name
    SIM
    Manufacturer
    SIMAVITA PTY LIMITED
    Date Cleared
    2013-08-22

    (139 days)

    Product Code
    KPN
    Regulation Number
    876.2040
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIMAVITA PTY LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SIM™ (Smart Incontinence Management) is indicated for use by healthcare professionals to remotely monitor wetness events, and collect, transmit and report wetness events and other medical information from multiple patients within a clinical setting (e.g., hospitals, skilled nursing facilities, residential care facilities), to establish effective management care plans for continence events.
    Device Description
    SIM™ consists of disposable incontinence pads with embedded sensors, a wireless transceiver, hardware, and software.
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