QJS · Class II · 21 CFR 862.1356

FDA Product Code QJS: Interoperable Automated Glycemic Controller, Insulin Suspend

An Interoperable Automated Glycemic Controller, Insulin Suspend, Is A Device That Temporarily Suspend And Resumes Insulin Infusion From A Connected Infusion Pump Based On Specified Thresholds And Input Glucose Levels. Interoperable Automated Glycemic Controllers, Insulin Suspend, Are Designed To Reliably And Securely Communicate With Digitally Connected Devices To Allow Insulin Delivery Suspension And Resumption Commands To Be Sent, Received, Executed, And Confirmed. Interoperable Automated Glycemic Controllers, Insulin Suspend, Are Intended To Be Used In Conjunction With Digitally Connected Devices For The Purpose Of Maintaining Glycemic Control.

1
Total
1
Cleared
73d
Avg days
2020
Since

FDA 510(k) Cleared Interoperable Automated Glycemic Controller, Insulin Suspend Devices (Product Code QJS)

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

About Product Code QJS - Regulatory Context