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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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).
Product CodeNZE
Regulation Number 870.5900
Device Class 2


Premarket Reviews
ManufacturerDecision
GLOBAL HEALTHCARE SG SDN. BHD
  SUBSTANTIALLY EQUIVALENT 1
ZOLL CIRCULATION, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Blister 1 1
Unspecified Tissue Injury 1 1

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