DeviceClearance

K162564

Substantially Equivalent

Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83 Blood Glucose Monitoring System, Medisign GH81 BT Blood Glucose Monitoring System, Medisign GH82 BT Blood Glucose Monitoring System, Medisign GH83 BT Blood Glucose Monitoring System

Applicant
Tianjin Empecs Medical Device Co., Ltd.
Product code
NBW
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tianjin, CN
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, through . 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.