Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System
Medical specialty
Unknown
Device class
3
Review panel
CH
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
The device is intended to measure glucose in interstitial fluid. It is intended to provide those measurements as inputs to appropriately qualified digitally connected devices, including automated insulin dosing systems, as determined by FDA.