Cleared Traditional

MAC VU360 Resting ECG Analysis System

K173830 · Ge Medical Systems Information Technologies, Inc. · Cardiovascular
Sep 2018
Decision
274d
Days
Class 2
Risk

About This 510(k) Submission

K173830 is an FDA 510(k) clearance for the MAC VU360 Resting ECG Analysis System, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Ge Medical Systems Information Technologies, Inc. (Wauwatosa, US). The FDA issued a Cleared decision on September 18, 2018, 274 days after receiving the submission on December 18, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K173830 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2017
Decision Date September 18, 2018
Days to Decision 274 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DPS — Electrocardiograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2340

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