K100406

Substantially Equivalent

FORA V20 BLOOD GLUCOSE MONITORING SYSTEM

Applicant: Taidoc Technology Corporation
Product code: CGA
Advisory panel: Clinical Chemistry
Date received: 2010-02-16
Decision date: 2010-05-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Taipei County, TW

Adverse events under product code CGA

product code CGA

Death: 2
Malfunction: 1,816
Total: 1,818

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.