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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device flowmeter, tube, thorpe, back-pressure compensated
Regulation Description Compensated thorpe tube flowmeter.
Product CodeCAX
Regulation Number 868.2340
Device Class 1


Premarket Reviews
ManufacturerDecision
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PRECISION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Inaccurate flowrate 1
Leak 1
Use of Device Issue 1
Environmental control or utility issue 1
Inadequate user interface 1
Total Device Problems 5

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

Recalls
Manufacturer Recall Class Date Posted
1 Porter Instrument Co Inc II Oct-31-2008

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