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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 K834503
Device Name PROFILE URODYNAMIC MONITORING SYS
Applicant
BROWNE MEDICAL, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
BROWNE MEDICAL, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.1620
Classification Product Code
FAP  
Date Received12/21/1983
Decision Date 02/21/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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