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MAC 600 Resting ECG Analysis System

by GE Medical Systems Information Technologies, Inc.

510(k) K103765

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K103765↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK103765 Date17 May 2011ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
DPS
Device class
Class II
Regulation
21 CFR Part 870.2340
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The MAC 600 Resting ECG Analysis System is a medical device classified as an electrocardiograph, designed for recording and analyzing resting electrocardiogram (ECG) waveforms. It provides diagnostic information by capturing the electrical activity of the heart, enabling clinicians to assess cardiac rhythm, identify arrhythmias, and evaluate myocardial function.

This system is intended for use in clinical settings, including hospitals and diagnostic laboratories, and is supplied as a reusable device. It is regulated under FDA 510(k) clearance (K103765) and EU MDR compliance, ensuring adherence to safety and performance standards. The device operates in non-MRI environments and requires proper calibration and maintenance as specified by the manufacturer.

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