510(k) K193155

Nipro Dry Complete Dry Acid Concentrate for Hemodialysis by Nipro Renal Solutions USA, Corp. — Product Code KPO

K193155 is an FDA 510(k) premarket notification submitted by Nipro Renal Solutions USA, Corp. for the device "Nipro Dry Complete Dry Acid Concentrate for Hemodialysis". The FDA issued a decision of Substantially Equivalent on November 25, 2020. The device falls under product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)), a Class II device regulated under 21 CFR 876.5820. Nipro Renal Solutions USA, Corp. has at least 1 other 510(k) clearance on record.