K170143

Substantially Equivalent

GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B,

Applicant: Bionime Corporation
Product code: NBW
Advisory panel: Clinical Chemistry
Date received: 2017-01-17
Decision date: 2017-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung 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.