Sensor, Glucose, Implanted, Non-Adjunctive Use
The Sensor, Glucose, Implanted, Non-Adjunctive Use is an implanted glucose sensor intended to determine glucose levels and the direction and rate of change in people with diabetes, and is specifically indicated to replace information obtained from standard blood glucose monitoring devices for making treatment decisions. It also provides historical glucose data to facilitate long-term therapy adjustments. It is classified as FDA Class 3, the highest risk category requiring Premarket Approval (PMA), reviewed by the Clinical Chemistry panel. The product code is QHJ, with no regulation number assigned, and the device carries an implant flag, indicating it is surgically placed within the body.
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Basic Information
- Product Code
- QHJ
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- CH
- Submission Type
- 2
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.