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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device laryngoscope, nasopharyngoscope
Regulation Description Nasopharyngoscope (flexible or rigid) and accessories.
Product CodeEQN
Regulation Number 874.4760
Device Class 2


Premarket Reviews
ManufacturerDecision
KINETIC CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Break 3
Device Cleaning Issue 2
Overheating of device or device component 2
Peeled 2
Material separation 1
Component(s), overheating of 1
Fracture 1
Total Device Problems 12

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

Recalls
Manufacturer Recall Class Date Posted
1 Bomimed Inc II May-03-2012

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