Product code QHJ

Device name

Sensor, Glucose, Implanted, Non-Adjunctive Use

Medical specialty

Unknown

Device class

3

Review panel

CH

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

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.

Source

FDA openFDA device classification dataset