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510(k) K761083

Device
BARD URINE METER W/ BAG
Applicant
C.R. BARD, INC.
510(k) number
K761083
Product code
EXR  
Decision
Substantially Equivalent (SESE)
Decision date
1977-01-26
Date received
1976-11-19
Regulation
876.1800
Classification name
Urinometer, Mechanical
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EXR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K934142URINARY DRAINAGE BAGKey Medical Services, Inc.1994-05-17
K935578URINE METERPuritas Health Care, Inc.1993-12-17
K911258KENDALL PEDIATRIC URINE METERKendall Healthcare Products Co. Div.Of Tyco Health1991-04-25
K896732UNOMETER 500Unoplast A/S1990-11-02
K870240COMPRESS AND SKULLCAP, HEAD DRESSINGFraass Survival Systems, Inc.1987-02-20
K771561DOVER URINE METERWill Ross Co.1977-09-07
K770423URINE TESTER, MODEL NO. 707Brother Scientific Products, Inc.1977-06-03
K770939URINE TESTER, MODEL 701Brother Scientific Products, Inc.1977-06-03

Legacy Summary#

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FDA Review#

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