EXY — Uroflowmeter Class II

FDA Device Classification

Classification Details

Product Code
EXY
Device Class
Class II
Regulation Number
876.1800
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K142425be technologiesUroflowmeterOctober 27, 2014
K022721w.o.m. world of medicineUROPOWERAugust 26, 2003
K971913albyn medicalGR100F URINE FLOWMETERSeptember 19, 1997
K953999dantec medicalDANTEC DA CAPONovember 21, 1995
K951442synectics medicalFLOLABAugust 24, 1995
K944972myo/kinetic systemsURO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRYMarch 8, 1995
K945495fiberoptic sensor technlogies4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTIONFebruary 9, 1995
K941105laborie medical techUORCAP,MODEL NUMBER UDS-UCAPMay 10, 1994
K904557life-tech intlMICROFLODecember 28, 1990
K902408diagnostic ultrasoundDIAGNOSTIC ULTRASOUND UFS 1005August 10, 1990
K900770biodan medical systemsHOME URODATA SYSTEM(TM)June 8, 1990
K894968eutectic electronicsULTRACOMPACTNovember 8, 1989
K880504mct medicalMCT MEDICAL BROWNE UROSCAN URODYNAMICJune 17, 1988
K873695life-tech intlMODEL 1859 TUMI/PRESSURE MODULEJanuary 27, 1988
K872077life-tech intlMODEL 1858 CAVRO/PRESSURE MODULEAugust 27, 1987
K770897life-tech instrumentsURODYNAMIC INSTRUMENTSJune 3, 1977