GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025— 510(k) K091168

Substantially Equivalent

Infopia Co, Ltd.

FDA 510(k) clearance K091168 for GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025, Substantially Equivalent on 2010-05-27. Applicant: Infopia Co, Ltd..

Clearance details

Applicant: Infopia Co, Ltd.
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2009-04-22
Decision date: 2010-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

Download summary PDF View on FDA.gov ↗

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.