MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM— 510(k) K042177

Name: FDA 510(k) clearance K042177
Creator: U.S. Food and Drug Administration
Published: 2004-08-27

Substantially Equivalent

Ge Medical Systems Information Technologies

FDA 510(k) clearance K042177 for MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM, Substantially Equivalent on 2004-08-27. Applicant: Ge Medical Systems Information Technologies. Device class: 2.

Clearance details

Applicant: Ge Medical Systems Information Technologies
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 2004-08-11
Decision date: 2004-08-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.