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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, hypothermia, intravenous, cooling
Regulation Description Thermal regulating system.
Product CodeNCX
Regulation Number 870.5900
Device Class 2


Premarket Reviews
ManufacturerDecision
ALSIUS CORP.
  SUBSTANTIALLY EQUIVALENT 5
  SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS 4
INNERCOOL THERAPIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDIVANCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
RADIANT INNOVATION, INC.
  SUBSTANTIALLY EQUIVALENT 3
  SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS 1
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 1 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Alsius Corporation II Feb-15-2007

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