FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K131013

Substantially Equivalent

Nova 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.

Clearance details

Applicant: Nova Biomedical Corporation
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2013-04-11
Decision date: 2013-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walham, MA, 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.