CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION— 510(k) K032370

Substantially Equivalent

Ge Medical Systems Information Technologies

FDA 510(k) clearance K032370 for CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION, Substantially Equivalent on 2003-08-13. Applicant: Ge Medical Systems Information Technologies.

Clearance details

Applicant
Ge Medical Systems Information Technologies
Product code
Code DSI
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Milwaukee, WI, US
Download summary PDFView 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, through . 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.