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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device calculator, predicted values, pulmonary function
Regulation Description Predictive pulmonary-function value calculator.
Product CodeBTY
Regulation Number 868.1890
Device Class 2


Premarket Reviews
ManufacturerDecision
CRITICARE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL GRAPHICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 1
SENSORMEDICS
  SUBSTANTIALLY EQUIVALENT 2
VIASYS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
Calibration issue 6
Incorrect or inadequate result 2
Failure to calibrate 2
Low test results 1
Application program issue 1
Device stops intermittently 1
Calibration error 1
Computer software issue 1
Contamination during use 1
Disinfection, inadequate/improper 1
Incorrect software programming calculations 1
Connection issue 1
Total Device Problems 19

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

Recalls
Manufacturer Recall Class Date Posted
1 Shape Medical Systems, Inc II Feb-05-2015
2 Shape Medical Systems, Inc II Jul-14-2014

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