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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device calculator, pulmonary function data
Regulation Description Pulmonary-function data calculator.
Product CodeBZC
Regulation Number 868.1880
Device Class 2


Premarket Reviews
ManufacturerDecision
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
INNOVISION A/S
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL GRAPHICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 1
NOVAMETRIX
  SUBSTANTIALLY EQUIVALENT 4
SENSORMEDICS
  SUBSTANTIALLY EQUIVALENT 2
VIASYS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Shock, electrical 2
Material frayed 1
Improper or incorrect procedure or method 1
Cable, defective 1
Total Device Problems 5

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 1 0 0 0 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Innovision A/S II Sep-08-2016
2 Philips Healthcare Inc. II Apr-08-2010

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