ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001— 510(k) K090332
Substantially EquivalentArkray Factory USA, Inc.
FDA 510(k) clearance K090332 for ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001, Substantially Equivalent on 2009-08-14. Applicant: Arkray Factory USA, Inc..
Clearance details
- Applicant
- Arkray Factory USA, Inc.
- Product code
- Code NBW
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Edina, MN, 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.