510(k) K925522

CENTRYSYSTEM 3 WITH CHARTS/BP OPTION by C.G.H. Medical, Inc. — Product Code KOC

K925522 is an FDA 510(k) premarket notification submitted by C.G.H. Medical, Inc. for the device "CENTRYSYSTEM 3 WITH CHARTS/BP OPTION". The FDA issued a decision of Substantially Equivalent on September 30, 1994. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), a Class II device regulated under 21 CFR 876.5820. C.G.H. Medical, Inc. has at least 10 other 510(k) clearances on record.