Cleared Traditional

K203786 - MAC 7 - Resting ECG Analysis System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K203786 · Ge Medical Systems Information Technologies, Inc. · Cardiovascular device

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Apr 2021

Decision

123d

Days

Class 2

Risk

K203786 is an FDA 510(k) clearance for the MAC 7 - Resting ECG Analysis System. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies, Inc. (Wauwatosa, US). The FDA issued a Cleared decision on April 30, 2021 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Ge Medical Systems Information Technologies, Inc. devices

Submission Details

510(k) Number	K203786 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

2d faster than avg

Panel avg: 125d · This submission: 123d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	DPS Electrocardiograph
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 870.2340

What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.