EXR · Class II · 21 CFR 876.1800

FDA Product Code EXR: Urinometer, Mechanical

Leading manufacturers include C.R. Bard, Inc., Fraass Survival Systems, Inc. and Unoplast A/S.

9
Total
9
Cleared
98d
Avg days
1977
Since

FDA 510(k) Cleared Urinometer, Mechanical Devices (Product Code EXR)

9 devices
1–9 of 9
Cleared May 17, 1994
URINARY DRAINAGE BAG
K934142
Key Medical Services, Inc.
Gastroenterology & Urology · 265d
Cleared Dec 17, 1993
URINE METER
K935578
Puritas Health Care, Inc.
Gastroenterology & Urology · 29d
Cleared Apr 25, 1991
KENDALL PEDIATRIC URINE METER
K911258
Kendall Healthcare Products Co. Div.Of Tyco Health
Gastroenterology & Urology · 34d
Cleared Nov 02, 1990
UNOMETER 500
K896732
Unoplast A/S
Gastroenterology & Urology · 337d
Cleared Feb 20, 1987
COMPRESS AND SKULLCAP, HEAD DRESSING
K870240
Fraass Survival Systems, Inc.
Gastroenterology & Urology · 30d
Cleared Jan 26, 1977
BARD URINE METER W/ BAG
K761083
C.R. Bard, Inc.
Gastroenterology & Urology · 68d

About Product Code EXR - Regulatory Context