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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device accessory to continuous ventilator (respirator)
Regulation Description Continuous ventilator.
Product CodeMOD
Regulation Number 868.5895
Device Class 2


Premarket Reviews
ManufacturerDecision
Cardiopulmonary Corp.
  SUBSTANTIALLY EQUIVALENT 2
IMPACT INSTRUMENTATION, INC.
  SUBSTANTIALLY EQUIVALENT 1
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 1
NEWPORT
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Component(s), broken 2
Mechanical issue 2
Total Device Problems 4

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


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