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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device oximeter, ear
Regulation Description Ear oximeter.
Product CodeDPZ
Regulation Number 870.2710
Device Class 2


Premarket Reviews
ManufacturerDecision
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Use of Device Issue 1
Improper or incorrect procedure or method 1
Total Device Problems 2

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 1 1 0 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 GE Healthcare, LLC II Sep-14-2011
2 Ge Healthcare, Llc II Jun-22-2010

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