SFI

Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System

Product code: SFI
Device name: Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System
Device class: Class 3
Medical specialty: Unknown
Marketing pathway: PMA

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: SFI

Classification and pathway per current FDA publications. Data from openFDA (CC0).