NZE — Hyperthermia Monitor Class II
FDA product code NZE covers "Hyperthermia Monitor", a Class II medical device regulated under 21 CFR 870.5900. Submissions are reviewed by the Cardiovascular panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NZE
- Device Class
- Class II
- Regulation Number
- 870.5900
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250979 | zoll circulation | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Managem | October 15, 2025 |
| K240933 | global healthcare sg sdn. bhd | CarbonCool® System | March 18, 2025 |
| K231182 | zoll circulation | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Managem | November 3, 2023 |
| K162523 | braincool | The IQool System | May 3, 2017 |
| K100071 | emcools emergency medical cooling systems | EMCOOLSPAD | October 12, 2010 |
| K061023 | life recovery systems hd | THERMOSUIT SYSTEM | September 20, 2006 |