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510(k) Data Aggregation

    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?
    Applicant Name (Manufacturer) :

    ALBYN MEDICAL LTD.

    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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