Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus— 510(k) K173638

Substantially Equivalent

Bionime Corporation

FDA 510(k) clearance K173638 for Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus, Substantially Equivalent on 2018-08-17. Applicant: Bionime Corporation.

Clearance details

Applicant: Bionime Corporation
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2017-11-24
Decision date: 2018-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung City, TW

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.