DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080— 510(k) K090628

Substantially Equivalent

Bayer Healthcare, LLC

FDA 510(k) clearance K090628 for DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080, Substantially Equivalent on 2009-12-04. Applicant: Bayer Healthcare, LLC.

Clearance details

Applicant: Bayer Healthcare, LLC
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2009-03-09
Decision date: 2009-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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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.