CARDIOSOFT/CASE CARDIAC TESTING SYSTEM— 510(k) K031561

Substantially Equivalent

Ge Medical Systems Information Technologies

FDA 510(k) clearance K031561 for CARDIOSOFT/CASE CARDIAC TESTING SYSTEM, Substantially Equivalent on 2003-08-01. Applicant: Ge Medical Systems Information Technologies.

Clearance details

Applicant: Ge Medical Systems Information Technologies
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2003-05-19
Decision date: 2003-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

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.