510(k) K162768

ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables by Integral Process Sas — Product Code DSA

K162768 is an FDA 510(k) premarket notification submitted by Integral Process Sas for the device "ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables". The FDA issued a decision of Substantially Equivalent on August 16, 2017. The device falls under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)), a Class II device regulated under 21 CFR 870.2900. Integral Process Sas has at least 1 other 510(k) clearance on record.