510(k) K233213

NxStage PureFlow Solution by Nxstage Medical, Inc. — Product Code KPO

K233213 is an FDA 510(k) premarket notification submitted by Nxstage Medical, Inc. for the device "NxStage PureFlow Solution". The FDA issued a decision of Substantially Equivalent on January 18, 2024. The device falls under product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)), a Class II device regulated under 21 CFR 876.5820. Nxstage Medical, Inc. has at least 10 other 510(k) clearances on record.