510(k) K990010

ALTHIN MEDICAL AB ALTRACART II by Althin Medical AB — Product Code KPO

K990010 is an FDA 510(k) premarket notification submitted by Althin Medical AB for the device "ALTHIN MEDICAL AB ALTRACART II". The FDA issued a decision of Substantially Equivalent on April 15, 1999. The device falls under product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)), a Class II device regulated under 21 CFR 876.5820. Althin Medical AB has at least 6 other 510(k) clearances on record.