510(k) K901478

DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION by Delmed, Inc. — Product Code FKX

K901478 is an FDA 510(k) premarket notification submitted by Delmed, Inc. for the device "DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION". The FDA issued a decision of Substantially Equivalent on July 27, 1990. The device falls under product code FKX (System, Peritoneal, Automatic Delivery), a Class II device regulated under 21 CFR 876.5630. Delmed, Inc. has at least 10 other 510(k) clearances on record.