FDA Product Code SAF: Integrated Continuous Glucose Monitor For Non-intensive Glucose Monitoring, Over-the-counter
An Integrated Continuous Glucose Monitoring System (icgm) For Non-intensive Glucose Monitoring Is Intended To Automatically Measure Glucose In Bodily Fluids Continuously Or Frequently For A Specified Period Of Time To Detect Euglycemic And Dysglycemic Glucose Levels In Persons Who Are Not On Insulin And Do Not Have A Significant Risk Of Problematic Hypoglycemia. Icgm Systems For Non-intensive Glucose Monitoring Are Designed To Reliably And Securely Transmit Glucose Measurement Data To Digitally Connected Devices, Excluding Devices Intended To Control The Delivery Of Insulin, And Are Intended To Be Used Alone Or In Conjunction With These Digitally Connected Medical Devices. Device Output Should Not Be Used To Make Treatment Decisions Without Consulting With A Qualified Healthcare Professional.
Leading manufacturers include Dexcom, Inc..
List of Integrated Continuous Glucose Monitor For Non-intensive Glucose Monitoring, Over-the-counter devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Integrated Continuous Glucose Monitor For Non-intensive Glucose Monitoring, Over-the-counter devices (product code SAF). 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 →