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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stethoscope, esophageal, with electrical conductors
Regulation Description Esophageal stethoscope with electrical conductors.
Product CodeBZT
Regulation Number 868.1920
Device Class 2


Premarket Reviews
ManufacturerDecision
CATHETER RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
CINCINNATI SUB-ZERO PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEROYAL
  SUBSTANTIALLY EQUIVALENT 2
INAMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL COMPONENTS
  SUBSTANTIALLY EQUIVALENT 1
PORTEX, INC.
  SUBSTANTIALLY EQUIVALENT 2
PRIMROSE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RESPIRATORY SUPPORT PRODUCTS, INC. (RSP)
  SUBSTANTIALLY EQUIVALENT 2
SHERIDAN CATHETER CORP.
  SUBSTANTIALLY EQUIVALENT 4
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Material fragmentation 2
Loose or intermittent connection 2
Use of Device Issue 2
Device displays error message 2
Electrical issue 1
Defective component 1
Incorrect measurement 1
Device, or device fragments remain in patient 1
Incorrect or inadequate result 1
Device inoperable 1
Total Device Problems 14

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 Cincinnati Sub-Zero Products Inc II Jan-11-2012

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