NOVA ONE BLOOD GLUCOSE MONITOR— 510(k) K122435

Substantially Equivalent

Nova Biomedical Corporation

FDA 510(k) clearance K122435 for NOVA ONE BLOOD GLUCOSE MONITOR, Substantially Equivalent on 2012-12-20. Applicant: Nova Biomedical Corporation.

Clearance details

Applicant: Nova Biomedical Corporation
Product code: Code LFR
Advisory panel: Clinical Chemistry
Date received: 2012-08-10
Decision date: 2012-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walham, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LFR

product code LFR

Death: 3
Malfunction: 1,634
Total: 1,637

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.