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U.S. Department of Health and Human Services

Product Classification

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Device hyperthermia monitor
Regulation Description Thermal regulating system.
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).
Physical State Any application of external cooling methods (circulating water blankets/mattresses, circulating air blankets, cooling pads, cooling basins, etc.)
Technical Method Any application of external cooling methods (circulating water blankets/mattresses, circulating air blankets, cooling pads, cooling basins, etc.)
Target Area Entire body surface
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeNZE
Premarket Review Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type 510(k)
Regulation Number 870.5900
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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