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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device monitor, oxygen, cutaneous, for infant not under gas anesthesia
Regulation Description Cutaneous oxygen (PcO2) monitor.
Product CodeKLK
Regulation Number 868.2500
Device Class 2


Premarket Reviews
ManufacturerDecision
ANALOGIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 2
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 2
NOVAMETRIX
  SUBSTANTIALLY EQUIVALENT 13
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Use of Device Issue 1
Total Device Problems 1

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


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