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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device monitor, carbon-dioxide, cutaneous
Regulation Description Cutaneous carbon dioxide (PcCO[bdi2]) monitor.
Product CodeLKD
Regulation Number 868.2480
Device Class 2


Premarket Reviews
ManufacturerDecision
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 1
NOVAMETRIX
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
RADIOMETER
  SUBSTANTIALLY EQUIVALENT 2
S & W MEDICO TEKNIK
  SUBSTANTIALLY EQUIVALENT 1
SECHRIST INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 1 1 2 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Philips Healthcare Inc. II Apr-08-2010
2 Radiometer America Inc II Dec-01-2011
3 Sentec AG II Nov-22-2012
4 Sentec AG II Aug-13-2012

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