K131173

Substantially Equivalent

FIA Blood Glucose Monitoring System (G2)

Applicant: Hmd Biomedical, Inc.
Product code: NBW
Advisory panel: Clinical Chemistry
Date received: 2013-04-25
Decision date: 2014-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xinpu Township, Hsinchu County, TW

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.