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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device hyperthermia monitor
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).
Product CodeNZE
Regulation Number 870.5900
Device Class 2


Premarket Reviews
ManufacturerDecision
ZOLL CIRCULATION, INC
  SUBSTANTIALLY EQUIVALENT 1

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