510(k) K844503

UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK by Epcom Medical Systems, Inc. — Product Code FAP

K844503 is an FDA 510(k) premarket notification submitted by Epcom Medical Systems, Inc. for the device "UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK". The FDA issued a decision of Substantially Equivalent on January 2, 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. Epcom Medical Systems, Inc. has at least 10 other 510(k) clearances on record.