# Sensor, Glucose, Implanted, Non-Adjunctive Use
> **Product code: QHJ** · Class III — High Risk (PMA approval required, life-sustaining) · Unknown · —
## Classification
- **FDA Product Code:** QHJ
- **Device class:** Class III — High Risk (PMA approval required, life-sustaining)
- **Regulation:** —
- **Review panel:** CH
- **Medical specialty:** Unknown
- **Submission type:** 2
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** Y
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 7
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QHJ)
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