510(k) K233950

pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) by Fresenius Medical Care Renal Therapies Group, LLC — Product Code KPO

K233950 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care Renal Therapies Group, LLC for the device "pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)". The FDA issued a decision of Substantially Equivalent on May 10, 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. Fresenius Medical Care Renal Therapies Group, LLC has at least 10 other 510(k) clearances on record.