DeviceClearance

K240640

Substantially Equivalent

Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System

Applicant
Sejoy Biomedical Co., Ltd.
Product code
NBW
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hangzhou City, 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.