MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K111456

Substantially Equivalent

Tianjin Empecs Medical Device Co., Ltd.

FDA 510(k) clearance K111456 for MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2012-02-28. Applicant: Tianjin Empecs Medical Device Co., Ltd..

Clearance details

Applicant: Tianjin Empecs Medical Device Co., Ltd.
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2011-05-25
Decision date: 2012-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Manan-Gu Anyang-Si Gyeonggi-Do, KR

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.