QII · Class II · 21 CFR 862.1355

FDA Product Code QII: Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-time Use

An Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-time Use Is A Continuous Glucose Recording Device Indicated For Use As Directed By A Physician Either For The Real-time Management Of Diabetes At Home Or For The Retrospective Discovery, Analysis, And Interpretation Of Glycemic Variability In Persons Age 2 And Older By Healthcare Professionals To Guide Appropriate Patient Management. The System Is Also Intended To Interface With Digitally Connected Devices.

1
Total
1
Cleared
90d
Avg days
2019
Since

FDA 510(k) Cleared Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-time Use Devices (Product Code QII)

1 devices
1–1 of 1
No devices found for this product code.

About Product Code QII - Regulatory Context