510(k) K202739— Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System

Substantially Equivalent

Bioland Technology, Ltd.

Clearance details

Applicant: Bioland Technology, Ltd.
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2020-09-18
Decision date: 2022-08-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Shenzhen, CN

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.