Cleared Abbreviated

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

K162768 · Integral Process Sas · Cardiovascular
Aug 2017
Decision
320d
Days
Class 2
Risk

About This 510(k) Submission

K162768 is an FDA 510(k) clearance for the 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, a Cable, Transducer And Electrode, Patient, (including Connector) (Class II — Special Controls, product code DSA), submitted by Integral Process Sas (Conflans Sainte Honorine, FR). The FDA issued a Cleared decision on August 16, 2017, 320 days after receiving the submission on September 30, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2900.

Submission Details

510(k) Number K162768 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2016
Decision Date August 16, 2017
Days to Decision 320 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSA — Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2900

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