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510(k) Data Aggregation

    K Number
    K142425
    Device Name
    Uroflowmeter
    Manufacturer
    BE TECHNOLOGIES, INC.
    Date Cleared
    2014-10-27

    (59 days)

    Product Code
    EXY
    Regulation Number
    876.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    BE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UFM is a urine flow measuring system.
    Device Description
    The UFS provides real-time urine flow measurement, in men, by analyzing specific sound areas that are produced by the urine as it impacts the water surface. The system consists of a laptop with proprietary software and a microphone to capture the sound. Real time urine flow is displayed on the monitor during the test and Maximum Flow; Average Flow; Volume; Time to Maximum and Void Time are calculated and displayed on the monitor upon completion of the test.
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