EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017— 510(k) K101037

Substantially Equivalent

Eps Bio Technology Corp.

FDA 510(k) clearance K101037 for EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017, Substantially Equivalent on 2011-05-23. Applicant: Eps Bio Technology Corp..

Clearance details

Applicant: Eps Bio Technology Corp.
Product code: Code LFR
Advisory panel: Clinical Chemistry
Date received: 2010-04-14
Decision date: 2011-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu, TW

Download summary PDF View on FDA.gov ↗

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.