FDA 510(k) Applications for Medical Device Product Code "EXY"
(Uroflowmeter)

FDA 510(k) Number Applicant Device Name Decision Date
K971913 ALBYN MEDICAL LTD. GR100F URINE FLOWMETER 09/19/1997
K142425 BE TECHNOLOGIES, INC. Uroflowmeter 10/27/2014
K900770 BIODAN MEDICAL SYSTEMS, LTD. HOME URODATA SYSTEM(TM) 06/08/1990
K953999 DANTEC MEDICAL, INC. DANTEC DA CAPO 11/21/1995
K902408 DIAGNOSTIC ULTRASOUND CORP. DIAGNOSTIC ULTRASOUND UFS 1005 08/10/1990
K894968 EUTECTIC ELECTRONICS, INC. ULTRACOMPACT 11/08/1989
K945495 FIBEROPTIC SENSOR TECHNLOGIES, INC. 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION 02/09/1995
K941105 LABORIE MEDICAL TECH, INC. UORCAP,MODEL NUMBER UDS-UCAP 05/10/1994
K770897 LIFE-TECH INSTRUMENTS, INC. URODYNAMIC INSTRUMENTS 06/03/1977
K904557 LIFE-TECH INTL., INC. MICROFLO 12/28/1990
K873695 LIFE-TECH INTL., INC. MODEL 1859 TUMI/PRESSURE MODULE 01/27/1988
K880504 MCT MEDICAL, INC. MCT MEDICAL BROWNE UROSCAN URODYNAMIC 06/17/1988
K944972 MYO/KINETIC SYSTEMS, INC. URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY 03/08/1995
K951442 SYNECTICS MEDICAL, INC. FLOLAB 08/24/1995
K022721 W.O.M. WORLD OF MEDICINE AG UROPOWER 08/26/2003


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