510(k) K832053

SINGLE PATIENT SYS. II MODEL DM-450 by Extracorporeal Medical Specialities, Inc. — Product Code KOC

K832053 is an FDA 510(k) premarket notification submitted by Extracorporeal Medical Specialities, Inc. for the device "SINGLE PATIENT SYS. II MODEL DM-450". The FDA issued a decision of Substantially Equivalent on September 29, 1983. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), a Class II device regulated under 21 CFR 876.5820. Extracorporeal Medical Specialities, Inc. has at least 10 other 510(k) clearances on record.