K111728

Substantially Equivalent

EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM

Applicant: Eps Bio Technology Corp.
Product code: CGA
Advisory panel: Clinical Chemistry
Date received: 2011-06-20
Decision date: 2011-09-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Hsinchu, 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.