CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM— 510(k) K103678

Substantially Equivalent

Ge Medical Systems Information Technologies GmbH

FDA 510(k) clearance K103678 for CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM, Substantially Equivalent on 2011-02-16. Applicant: Ge Medical Systems Information Technologies GmbH.

Clearance details

Applicant: Ge Medical Systems Information Technologies GmbH
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2010-12-16
Decision date: 2011-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Freiburg,Baden Wurttemberg, DE

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.