CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM— 510(k) K091820
Substantially EquivalentBayer Healthcare
FDA 510(k) clearance K091820 for CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM, Substantially Equivalent on 2009-08-26. Applicant: Bayer Healthcare.
Clearance details
- Applicant
- Bayer Healthcare
- Product code
- Code NBW
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mishawaka, IN, US
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, through . 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.