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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device plethysmograph, impedance
Regulation Description Impedance plethysmograph.
Product CodeDSB
Regulation Number 870.2770
Device Class 2


Premarket Reviews
ManufacturerDecision
ANALOGIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
CARDIODYNAMICS INTERNATIONAL CORP.
  SUBSTANTIALLY EQUIVALENT 11
CHEETAH MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
CNSYSTEMS MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
CONMED
  SUBSTANTIALLY EQUIVALENT 1
DYNATRONICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
IMAGYN MEDICAL TECHNOLOGIES
  SE - WITH LIMITATIONS 2
INTERNATIONAL MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
N.I. SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
SONOSITE,INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect or inadequate result 1
Total Device Problems 1

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

Recalls
Manufacturer Recall Class Date Posted
1 Partners In Medicine Llc II Jan-04-2016

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