NZEClass II
Hyperthermia Monitor
21 CFR 870.5900 / Cardiovascular
NZE is the FDA product code for Hyperthermia Monitor, a class II device type, regulated under 21 CFR 870.5900. FDA's definition for this code reads: "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)". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- NZE
- Device name
- Hyperthermia Monitor
- FDA 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).
- Regulation
- 21 CFR 870.5900
- Device class
- Class II
- Review panel
- Cardiovascular
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 6
- Ingested recalls
- 1
Clearances, product code NZE
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2010 | 1 |
| 2017 | 1 |
| 2023 | 1 |
| 2025 | 2 |
Applicants with the most clearances
Product code NZE| Applicant | Clearances |
|---|---|
| ZOLL Circulation, Inc. | 2 |
| Braincool AB | 1 |
| Emcools Emergency Medical Cooling Systems AG | 1 |
| Global Healthcare SG Sdn. Bhd | 1 |
| Life Recovery Systems HD, LLC | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.