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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device spectral absorb. curve, oxyhemoglobin, carboxyhemoglobin, carbon-monoxide
Regulation Description Carbon monoxide test system.
Product CodeJKS
Regulation Number 862.3220
Device Class 1


Premarket Reviews
ManufacturerDecision
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1

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

Recalls
Manufacturer Recall Class Date Posted
1 International Technidyne Corp. II Aug-06-2008

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