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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
EMCOOLS EMERGENCY MEDICAL COOLING SYSTEMS AG
  SUBSTANTIALLY EQUIVALENT 1
LIFE RECOVERY SYSTEMS HD, LLC
  SUBSTANTIALLY EQUIVALENT 1

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 1 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Life Recovery Systems HD, LLC II Jan-11-2012

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