510(k) K910285

BROWNE MEDICAL SYST.INC STAND-ALONE WATER PUMP by Browne Medical Systems, Inc. — Product Code FAP

K910285 is an FDA 510(k) premarket notification submitted by Browne Medical Systems, Inc. for the device "BROWNE MEDICAL SYST.INC STAND-ALONE WATER PUMP". The FDA issued a decision of Substantially Equivalent on April 2, 1991. 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 Systems, Inc. has at least 6 other 510(k) clearances on record.