Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System
SFI · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
SFI
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
CH
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.