DeviceClearance

K191450

Substantially Equivalent

Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System

Applicant
Dexcom, Inc.
Product code
QBJ
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
San Diego, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code QBJ

product code QBJ
Death
180
Injury
31,825
Malfunction
1,792,244
Other
36
Total
1,824,285

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.