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510(k) Data Aggregation
K Number
K142425Device Name
Uroflowmeter
Manufacturer
BE TECHNOLOGIES, INC.
Date Cleared
2014-10-27
(59 days)
Product Code
EXY
Regulation Number
876.1800Why 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
K022721Device Name
UROPOWER
Manufacturer
W.O.M. WORLD OF MEDICINE AG
Date Cleared
2003-08-26
(375 days)
Product Code
EXY
Regulation Number
876.1800Why 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
K971913Device Name
GR100F URINE FLOWMETER
Manufacturer
ALBYN MEDICAL LTD.
Date Cleared
1997-09-19
(120 days)
Product Code
EXY
Regulation Number
876.1800Why 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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