510(k) K910665— MODEL 556 MONITOR W/24-HR. TREND RECALL/MODIFIED

Substantially Equivalent

Ge Medical Systems Information Technologies

Clearance details

Applicant: Ge Medical Systems Information Technologies
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1991-02-11
Decision date: 1991-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wallingford, CT, US

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.