K201037

Substantially Equivalent

FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System

Applicant: Taidoc Technology Corporation
Product code: NBW
Advisory panel: Clinical Chemistry
Date received: 2020-04-20
Decision date: 2022-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, 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.