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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?
    Product Code :

    EXY

    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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    K Number
    K022721
    Device Name
    UROPOWER
    Manufacturer
    W.O.M. WORLD OF MEDICINE AG
    Date Cleared
    2003-08-26

    (375 days)

    Product Code
    EXY
    Regulation Number
    876.1800
    Why did this record match?
    Product Code :

    EXY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Uropower is a urine flow and volume measuring system intended for lay use to measure the urine volume and flow of men during the course of normal urination. The device is also intended to be used by health care professionals.
    Device Description
    The Uropower is a device intended to measure the urine flow and calculate the volume of males in order to identify micturition disturbances. It is designed to be used by health care professionals and by laymen. The system consists of a base unit, a urinal-flow-transducer and various mount elements. Due to its construction the transducer can be installed in a urinal. The user is guided by instructions shown on the LCD display of the base unit. The urinal flow transducer measures the flow of the urine in accordance with the through-flow-principle, a volume per time measurement. The base unit calculates the total voided volume, maximum flow rate, mean flow rate, total measuring time, time, time to max, flow and medical data like the flow index. All parameters are printed on a thermo card.
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    K Number
    K971913
    Device Name
    GR100F URINE FLOWMETER
    Manufacturer
    ALBYN MEDICAL LTD.
    Date Cleared
    1997-09-19

    (120 days)

    Product Code
    EXY
    Regulation Number
    876.1800
    Why did this record match?
    Product Code :

    EXY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GR100FS is intended to be used to measure urinary flow rates.
    Device Description
    Urine flowrate meter used for determining urine flow rate from patients performing normal micturition. The device functions by weighing the voided urine, the weight in grans approximates to the volume in ml the specific gravity of urine varies between 1.002 and 1.006 in infants and 1.025 in adults (95% ranges) and any inaccuracy is therefore no more than 2.5%. The urine is weighed as the urine flows using a straingauged load cell, the signal nutput from which is digitised. The flow volume is differentiated digitally to give the flow rate, which is printed on a paper chart recorder. The flowmeter uses algorithms to calculate the following parameters. - Total voided volume Volume at maximum flow Maximum Now rate Mcan flow rate Flow time Time of maximum flow The recorder is a table-top device connected to the load coll which supports a jug and which fits under either a commode chair or stand.
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