510(k) K821139

SPS-SINGLE PATIENT SYSTEM by Extracorporeal Medical Specialities, Inc. — Product Code FIR

K821139 is an FDA 510(k) premarket notification submitted by Extracorporeal Medical Specialities, Inc. for the device "SPS-SINGLE PATIENT SYSTEM". The FDA issued a decision of Substantially Equivalent on May 10, 1982. The device falls under product code FIR (Pump, Blood, Extra-Luminal), a Class II device regulated under 21 CFR 876.5820. Extracorporeal Medical Specialities, Inc. has at least 10 other 510(k) clearances on record.