K121207

Substantially Equivalent

EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM

Applicant: Eps Bio Technology Corp.
Product code: LFR
Advisory panel: Clinical Chemistry
Date received: 2012-04-20
Decision date: 2012-05-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Hsinchu, TW

Adverse events under product code LFR

product code LFR

Death: 3
Malfunction: 1,634
Total: 1,637

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.