Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Hyperthermia Monitor

FDA product code NZE · 6 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.5900
Review panel
CV
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2006-09-20 – 2025-10-15

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).

↑