SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System— 510(k) K153201

Substantially Equivalent

Sd Biosensor

FDA 510(k) clearance K153201 for SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System, Substantially Equivalent on 2016-06-24. Applicant: Sd Biosensor.

Clearance details

Applicant: Sd Biosensor
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2015-11-04
Decision date: 2016-06-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Suwon-Si, 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.