# Glucose Range Monitoring System
> **Product code: SFU** · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1359
## Classification
- **FDA Product Code:** SFU
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 862.1359
- **Review panel:** CH
- **Medical specialty:** Clinical Chemistry
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

A glucose range monitoring system (GRM) is intended to automatically measure glucose in the body and provide qualitative or semi-quantitative information about glucose levels or trends continuously or frequently.  GRM systems are intended to support general user awareness of glucose ranges related to glycemic control.  Outputs from GRM systems do not represent quantitative glucose concentration values and GRM systems are not intended to be used for acute medical decision-making, such as insulin dosing or medication adjustment.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=SFU)
---
*AI Analytics · CC0 1.0*