510(k) K061992— EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014

Substantially Equivalent

Eps Bio Technology Corp.

Clearance details

Applicant: Eps Bio Technology Corp.
Product code: Code CGA
Advisory panel: Clinical Chemistry
Date received: 2006-07-13
Decision date: 2006-09-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Hsinchu City, 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.