510(k) K834503

PROFILE URODYNAMIC MONITORING SYS by Browne Medical, Inc. — Product Code FAP

K834503 is an FDA 510(k) premarket notification submitted by Browne Medical, Inc. for the device "PROFILE URODYNAMIC MONITORING SYS". The FDA issued a decision of Substantially Equivalent on February 21, 1984. The device falls under product code FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device), a Class II device regulated under 21 CFR 876.1620. Browne Medical, Inc. has at least 3 other 510(k) clearances on record.