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NZEClass II

Hyperthermia Monitor

Cardiovascular · 21 CFR 870.5900

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).

MDR events10All time
Recalls1All time
Registered firms6Currently listed
510(k) clearances6All time

Event type breakdown

Injury8
Death1
Malfunction1