MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER— 510(k) K062976

Substantially Equivalent

Ge Medical Systems Information Technologies

FDA 510(k) clearance K062976 for MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER, Substantially Equivalent on 2007-03-16. Applicant: Ge Medical Systems Information Technologies.

Clearance details

Applicant: Ge Medical Systems Information Technologies
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 2006-09-29
Decision date: 2007-03-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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.