G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A— 510(k) K082201

Substantially Equivalent

U. S. Diagnostics, Inc.

FDA 510(k) clearance K082201 for G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A, Substantially Equivalent on 2009-02-20. Applicant: U. S. Diagnostics, Inc..

Clearance details

Applicant: U. S. Diagnostics, Inc.
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2008-08-05
Decision date: 2009-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, 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.