510(k) K240087

RT Carbon ECG Leads by Ivy Biomedical Systems, Inc. — Product Code DSA

K240087 is an FDA 510(k) premarket notification submitted by Ivy Biomedical Systems, Inc. for the device "RT Carbon ECG Leads". The FDA issued a decision of Substantially Equivalent on September 13, 2024. The device falls under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)), a Class II device regulated under 21 CFR 870.2900. Ivy Biomedical Systems, Inc. has at least 10 other 510(k) clearances on record.