510(k) K193542

Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 by Bellco Srl — Product Code KDI

K193542 is an FDA 510(k) premarket notification submitted by Bellco Srl for the device "Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22". The FDA issued a decision of Substantially Equivalent on October 8, 2020. 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. Bellco Srl has at least 2 other 510(k) clearances on record.