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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device analyzer, gas, oxygen, gaseous-phase
Regulation Description Oxygen gas analyzer.
Product CodeCCL
Regulation Number 868.1720
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO-MED
  SUBSTANTIALLY EQUIVALENT 1
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
GAMBRO
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 3
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
INVACARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
MAXTEC
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 1
NOVAMETRIX
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
PRECISION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SALTER LABS
  SUBSTANTIALLY EQUIVALENT 4
SIEMENS
  SUBSTANTIALLY EQUIVALENT 2
THORATEC CORP.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR TECHNOLOGY INCORPORATED
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Device inoperable 2
Device displays error message 2
Failure to deliver 2
Total Device Problems 6

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 1 0 0 0 0 2 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare II May-28-2015
2 GE Healthcare, LLC II Sep-09-2014
3 GE Healthcare, LLC II Jun-17-2014
4 Teleflex Medical II Dec-29-2009

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