510(k) K021060

FRESENIUS ICARE MONITORING SYSTEM by Fresenius Medical Care North America — Product Code FKP

K021060 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care North America for the device "FRESENIUS ICARE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on November 13, 2002. The device falls under product code FKP (System, Dialysate Delivery, Single Patient), a Class II device regulated under 21 CFR 876.5820. Fresenius Medical Care North America has at least 10 other 510(k) clearances on record.