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