K060661

Substantially Equivalent

MACTRODE 3

Applicant: Ge Medical Systems Information Technologies
Product code: DRX
Advisory panel: Cardiovascular
Date received: 2006-03-13
Decision date: 2006-04-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Milwaukee, WI, US

Adverse events under product code DRX

product code DRX

Death: 6
Injury: 476
Other: 2
Total: 484

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.