510(k) K802831

GAMBRO PERITONEAL DIALYSIS MONITOR by Gambro, Inc. — Product Code KPF

K802831 is an FDA 510(k) premarket notification submitted by Gambro, Inc. for the device "GAMBRO PERITONEAL DIALYSIS MONITOR". The FDA issued a decision of Substantially Equivalent on December 18, 1980. The device falls under product code KPF (System, Dialysate Delivery, Semi-Automatic, Peritoneal), a Class II device regulated under 21 CFR 876.5630. Gambro, Inc. has at least 10 other 510(k) clearances on record.