510(k) K182327

Patient Cables and Leadwires , Disposable ECG Leadwires by Orantech, Inc. — Product Code DSA

K182327 is an FDA 510(k) premarket notification submitted by Orantech, Inc. for the device "Patient Cables and Leadwires , Disposable ECG Leadwires". The FDA issued a decision of Substantially Equivalent on Jan 30, 2019. The device falls under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)), a Class II device regulated under 21 CFR 870.2900. Orantech, Inc. has 4 other 510(k) clearances on record.