K914889

Substantially Equivalent

GEMSCOM SERIES 3000

Applicant: General Devices
Product code: DRG
Advisory panel: Cardiovascular
Date received: 1991-10-31
Decision date: 1992-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bogota, NJ, US

Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

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.