GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System— 510(k) K150274

Substantially Equivalent

Infopia Co, Ltd.

FDA 510(k) clearance K150274 for GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System, Substantially Equivalent on 2015-08-26. Applicant: Infopia Co, Ltd..

Clearance details

Applicant: Infopia Co, Ltd.
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2015-02-04
Decision date: 2015-08-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Anyang, KR

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.