FDA Product Code QDK: Integrated Continuous Glucose Monitoring System For Non-intensive Diabetes Management
An Integrated Continuous Glucose Monitoring System For Non-intensive Diabetes Management Is Intended To Replace Finger Stick Blood Glucose Testing For Diabetes Treatment Decisions In Persons With Diabetes Who Do Not Have Significant Risk Of Severe Hypoglycemia. The Device Also Aids In The Detection Of Episodes Of Hyperglycemia And Hypoglycemia, Facilitating Long-term Therapy Adjustments. The Device Is Also Intended To Autonomously Communicate With Digitally Connected Devices. The Device Can Be Used Alone Or In Conjunction With These Digitally Connected Devices Or Services For The Purpose Of Managing Diabetes.
Leading manufacturers include Dexcom, Inc..
List of Integrated Continuous Glucose Monitoring System For Non-intensive Diabetes Management devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Integrated Continuous Glucose Monitoring System For Non-intensive Diabetes Management devices (product code QDK). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Chemistry FDA review panel. Browse all Chemistry devices →