510(k) K851483

UROBEI STRESS INCONTINENCE MONITOR by Browne Medical, Inc. — Product Code FAP

K851483 is an FDA 510(k) premarket notification submitted by Browne Medical, Inc. for the device "UROBEI STRESS INCONTINENCE MONITOR". The FDA issued a decision of Substantially Equivalent on August 7, 1985. 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.