EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2— 510(k) K070053

Substantially Equivalent

Eps Bio Technology Corp.

FDA 510(k) clearance K070053 for EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2, Substantially Equivalent on 2007-12-03. Applicant: Eps Bio Technology Corp..

Clearance details

Applicant: Eps Bio Technology Corp.
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2007-01-04
Decision date: 2007-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu City, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code NBW

product code NBW

Death: 18
Injury: 4,740
Malfunction: 42,679
Other: 6
Total: 47,443

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.