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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 uses other than for infant not under gas anesthesia
Regulation Description Cutaneous oxygen (PcO2) monitor.
Product CodeLPP
Regulation Number 868.2500
Device Class 2


Premarket Reviews
ManufacturerDecision
RADIOMETER
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 1
Total Device Problems 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 0 1 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Radiometer America Inc II Aug-08-2013

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