NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR— 510(k) K122688

Substantially Equivalent

Nova Biomedical Corporation

FDA 510(k) clearance K122688 for NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR, Substantially Equivalent on 2013-04-04. Applicant: Nova Biomedical Corporation.

Clearance details

Applicant: Nova Biomedical Corporation
Product code: Code LFR
Advisory panel: Clinical Chemistry
Date received: 2012-09-04
Decision date: 2013-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walham, MA, US

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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.