510(k) K875121

AMICON EQUALINE FLUID BALANCE SYSTEM by Amicon, Inc. — Product Code KPF

K875121 is an FDA 510(k) premarket notification submitted by Amicon, Inc. for the device "AMICON EQUALINE FLUID BALANCE SYSTEM". The FDA issued a decision of Substantially Equivalent on February 19, 1988. The device falls under product code KPF (System, Dialysate Delivery, Semi-Automatic, Peritoneal), a Class II device regulated under 21 CFR 876.5630. Amicon, Inc. has at least 10 other 510(k) clearances on record.