LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067— 510(k) K052762

Substantially Equivalent

Agamatrix, Inc.

FDA 510(k) clearance K052762 for LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067, Substantially Equivalent on 2006-01-23. Applicant: Agamatrix, Inc..

Clearance details

Applicant: Agamatrix, Inc.
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2005-09-30
Decision date: 2006-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, 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.