NZE — Hyperthermia Monitor Class II
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 |