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6 FDA 510(k) clearances · Product code

FDA profile

Official device name

Hyperthermia Monitor

Device class

Class II (moderate risk)

Regulation

21 CFR 870.5900

Medical specialty

Cardiovascular

Flags

Third-party review eligible

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).

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