# Hyperthermia Monitor
> **Product code: NZE** · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.5900
## Classification
- **FDA Product Code:** NZE
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 870.5900
- **Review panel:** CV
- **Medical specialty:** Cardiovascular
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## Definition

Intended to monitor and reduce a patient's temperature to mild hypothermia (not to go below 32 degrees celsius.  To induce mild hypothermia in hyperthermic patients e.g., heat stroke, fever (excluding fever related to head injury, cardiac arrest, or other severe medical conditions).

## Market data
- **Cleared 510(k) submissions:** 6
- **Registered establishments:** 4
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NZE)
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