EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K110435

Name: FDA 510(k) clearance K110435
Creator: U.S. Food and Drug Administration
Published: 2011-09-21

Substantially Equivalent

U. S. Diagnostics, Inc.

FDA 510(k) clearance K110435 for EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2011-09-21. Applicant: U. S. Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: U. S. Diagnostics, Inc.
Product code: Code NBW
Device class: Class 2
Regulation: 21 CFR 862.1345
Advisory panel: Clinical Chemistry
Date received: 2011-02-15
Decision date: 2011-09-21
Decision: Substantially Equivalent
Clearance type: Special
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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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.