Cleared Traditional

MAC 7 - Resting ECG Analysis System

K203786 · Ge Medical Systems Information Technologies, Inc. · Cardiovascular
Apr 2021
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K203786 is an FDA 510(k) clearance for the MAC 7 - 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 April 30, 2021, 123 days after receiving the submission on December 28, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K203786 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 2020
Decision Date April 30, 2021
Days to Decision 123 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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