EXY · Class II · 21 CFR 876.1800

FDA Product Code EXY: Uroflowmeter

Leading manufacturers include Life-Tech Intl., Inc., Be Technologies, Inc. and Life-Tech Instruments, Inc..

16
Total
16
Cleared
115d
Avg days
1977
Since

FDA 510(k) Cleared Uroflowmeter Devices (Product Code EXY)

16 devices
1–16 of 16
Cleared Oct 27, 2014
Uroflowmeter
K142425
Be Technologies, Inc.
Gastroenterology & Urology · 59d
Cleared Sep 19, 1997
GR100F URINE FLOWMETER
K971913
Albyn Medical , Ltd.
Gastroenterology & Urology · 120d
Cleared Nov 21, 1995
DANTEC DA CAPO
K953999
Dantec Medical, Inc.
Gastroenterology & Urology · 89d
Cleared Dec 28, 1990
MICROFLO
K904557
Life-Tech Intl., Inc.
Gastroenterology & Urology · 84d
Cleared Jun 08, 1990
HOME URODATA SYSTEM(TM)
K900770
Biodan Medical Systems, Ltd.
Gastroenterology & Urology · 112d
Cleared Jan 27, 1988
MODEL 1859 TUMI/PRESSURE MODULE
K873695
Life-Tech Intl., Inc.
Gastroenterology & Urology · 135d
Cleared Aug 27, 1987
MODEL 1858 CAVRO/PRESSURE MODULE
K872077
Life-Tech Intl., Inc.
Gastroenterology & Urology · 90d
Cleared Jun 03, 1977
URODYNAMIC INSTRUMENTS
K770897
Life-Tech Instruments, Inc.
Gastroenterology & Urology · 18d

About Product Code EXY - Regulatory Context