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510(k) K811925

Device
Uroflowmeter
Applicant
C.R. BARD, INC.
510(k) number
K811925
Product code
FFG
Decision
Substantially Equivalent (SESE)
Decision date
1981-09-08
Date received
1981-07-02
Regulation
876.1800
Classification name
Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
110 Marshall Dr. Warrendale PA US 15086 15086

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FFG#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K893827PEAK FLOW RATE METERLaytech Medical Co.1989-08-11
K883274SURGITEK (R) UROFLOW SYSTEMMedical Engineering Corp.1989-02-08
K850169ERIS URO-DIAGNOSTIC SYSTEMEris Medical Technology1985-04-22
K8443381URO-LOG HOME DIAGNOSTIC PACKEpcom Medical Systems, Inc.1985-02-25
K843442URINARY DRAINAGE CONTAINER 2013 WITHVital Metrics, Inc.1985-01-03
K843441URINARY DRAINAGE CONTAINER 2012-WITHVital Metrics, Inc.1985-01-03
K844030ACCUMETER ELECTRONIC URINEMETER SYSTEMTravenol Laboratories, S.A.1984-11-20
K843224UROPUMP MODEL 1711Life-Tech Intl., Inc.1984-10-19
K833043UROMETERBrowne Medical, Inc.1984-02-04
K813641VITAL METRICS URINE MONITORING SYSTEMVital Metrics, Inc.1982-03-01
K813082UREOFIX 500 URINE MEASURING SYSTEMBurron Medical Products, Inc.1981-12-31
K790894URITRON URINE METERJoseph F. Daniel, C.R.N.A.1979-09-07
K790365FLUID MEASUREMENT STANDHewlett-Packard Co.1979-05-11
K790663MODEL 1750 STANDING URINALLife-Tech Instruments, Inc.1979-04-24
K781597PM 2000 AUTOMATIC PATIENT CHAIRTime Motion System Co.1978-09-27