510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SFIClass III

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

Unknown
FDA source (opens on fda.gov)

SFI is the FDA product code for Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System, a class III device type. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
SFI
Device name
Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System
FDA 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.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code