ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001— 510(k) K053079

Substantially Equivalent

Hypoguard USA, Inc.

FDA 510(k) clearance K053079 for ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001, Substantially Equivalent on 2006-03-28. Applicant: Hypoguard USA, Inc..

Clearance details

Applicant: Hypoguard USA, Inc.
Product code: Code CGA
Advisory panel: Clinical Chemistry
Date received: 2005-11-02
Decision date: 2006-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edina, MN, US

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Adverse events under product code CGA

product code CGA

Death: 2
Malfunction: 1,816
Total: 1,818

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.