EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM— 510(k) K111728

Substantially Equivalent

Eps Bio Technology Corp.

FDA 510(k) clearance K111728 for EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM, Substantially Equivalent on 2011-09-16. Applicant: Eps Bio Technology Corp..

Clearance details

Applicant: Eps Bio Technology Corp.
Product code: 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

Download summary PDF View on FDA.gov ↗

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.