RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN— 510(k) K123008

Substantially Equivalent

Bionime Corporation

FDA 510(k) clearance K123008 for RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN, Substantially Equivalent on 2013-01-25. Applicant: Bionime Corporation.

Clearance details

Applicant: Bionime Corporation
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2012-09-27
Decision date: 2013-01-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Great Neck, 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.