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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
510(k) Number K910371
Device Name URODYNAMIC MEASURING SYSTEM
Applicant
BROWNE MEDICAL SYSTEMS, INC.
8990 SPRINGBROOK DRIVE,
SUITE 120
MINNEAPOLIS,  MN  55433
Applicant Contact DEBORAH HALL
Correspondent
BROWNE MEDICAL SYSTEMS, INC.
8990 SPRINGBROOK DRIVE,
SUITE 120
MINNEAPOLIS,  MN  55433
Correspondent Contact DEBORAH HALL
Regulation Number876.1620
Classification Product Code
FAP  
Date Received01/29/1991
Decision Date 05/15/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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