510(k) K220526

HD+12, HD+15 by Cardioline S.P.A — Product Code DRG

K220526 is an FDA 510(k) premarket notification submitted by Cardioline S.P.A for the device "HD+12, HD+15". The FDA issued a decision of Substantially Equivalent on May 15, 2023. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910. Cardioline S.P.A has at least 3 other 510(k) clearances on record.