510(k) K013733

SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET by Chf Solutions, Inc. — Product Code KDI

K013733 is an FDA 510(k) premarket notification submitted by Chf Solutions, Inc. for the device "SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET". The FDA issued a decision of Substantially Equivalent on June 3, 2002. The device falls under product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System), a Class II device regulated under 21 CFR 876.5860. Chf Solutions, Inc. has at least 10 other 510(k) clearances on record.