BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System— 510(k) K161299

Substantially Equivalent

Apex BioTechnology Corp.

FDA 510(k) clearance K161299 for BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System, Substantially Equivalent on 2016-12-23. Applicant: Apex BioTechnology Corp..

Clearance details

Applicant: Apex BioTechnology Corp.
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2016-05-09
Decision date: 2016-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu, 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.