Cleared Traditional

MAC 7 Resting ECG Analysis System

K251670 · Ge Medical Systems Information Technologies, Inc. · Cardiovascular
Jan 2026
Decision
241d
Days
Class 2
Risk

About This 510(k) Submission

K251670 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 January 26, 2026, 241 days after receiving the submission on May 30, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K251670 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 2025
Decision Date January 26, 2026
Days to Decision 241 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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