K073494

Substantially Equivalent

CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND -4226 AND ACHTUNG BLOOD GLUCOSE MONITORING

Applicant: Taidoc Technology Corporation
Product code: NBW
Advisory panel: Clinical Chemistry
Date received: 2007-12-12
Decision date: 2008-04-02
Decision: Substantially Equivalent
Clearance type: Special
Location: New Taipei City, TW

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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.