510(k) K131611

FRESENIUS DRY ACID DISSOLUTION UNITS by Fresenius Medical Care North America — Product Code KPO

K131611 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care North America for the device "FRESENIUS DRY ACID DISSOLUTION UNITS". The FDA issued a decision of Substantially Equivalent on August 29, 2013. 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 North America has at least 10 other 510(k) clearances on record.