NZE

Hyperthermia Monitor

Product code

NZE

Device name

Hyperthermia Monitor

Device class

Class 2

21 CFR

21 CFR 870.5900

Medical specialty

Cardiovascular

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (last 3 years)

3

Summaries archived here

3 (direct download)

510(k) clearances (all years, FDA)

6 (all years; only the last 3 years are listed here)

FDA classification 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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2025-10-15.

3 summaries are archived here for direct download.