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— 510(k) K162768

Substantially Equivalent

Integral Process Sas

FDA 510(k) clearance K162768 for 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, Substantially Equivalent on 2017-08-16. Applicant: Integral Process Sas.

Clearance details

Applicant: Integral Process Sas
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 2016-09-30
Decision date: 2017-08-16
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Conflans Sainte Honorine, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSA

product code DSA

Death: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.