510(k) K963330

URODYNAMIC ANALYSIS MODULE by Synectics Medical, Inc. — Product Code FAP

K963330 is an FDA 510(k) premarket notification submitted by Synectics Medical, Inc. for the device "URODYNAMIC ANALYSIS MODULE". The FDA issued a decision of Substantially Equivalent on April 3, 1997. The device falls under product code FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device), a Class II device regulated under 21 CFR 876.1620. Synectics Medical, Inc. has at least 4 other 510(k) clearances on record.