510(k) K170241— GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System

Substantially Equivalent

All Medicus Co., Ltd.

Clearance details

Applicant: All Medicus Co., Ltd.
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2017-01-26
Decision date: 2017-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anyang-Si, KR

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.