QHJ · Sensor, Glucose, Implanted, Non-Adjunctive Use

· Class 3

Overview

Product CodeQHJ
Device NameSensor, Glucose, Implanted, Non-Adjunctive Use
Device ClassClass 3
Review Panel
ImplantYes

Identification

A non-adjunctive implanted glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose information, facilitating long-term therapy adjustments.

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