# System, Breath Measurement
> **Product code: NRH** · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.1820
## Classification
- **FDA Product Code:** NRH
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 862.1820
- **Review panel:** CH
- **Medical specialty:** Clinical Chemistry
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

Breath measurement systems are used to measure constituents of exhaled breath as an aid in the diagnosis of sugar/nutrient malabsorbtion and other conditions.

## Market data
- **Cleared 510(k) submissions:** 4
- **Registered establishments:** 12
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NRH)
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