FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K131013
Substantially EquivalentNova Biomedical Corporation
FDA 510(k) clearance K131013 for FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2013-10-17. Applicant: Nova Biomedical Corporation. Device class: 2.
Clearance details
- Applicant
- Nova Biomedical Corporation
- Product code
- Product code NBW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walham, MA, US
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More clearances from Nova Biomedical Corporation
view allAdverse 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.