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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
CAREFUSION
  SUBSTANTIALLY EQUIVALENT 2
CIEL MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
COSMED S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
PULMONE ADVANCED MEDICAL DEVICES, LTD
  SUBSTANTIALLY EQUIVALENT 2
VYAIRE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Gas Leak 2
Output above Specifications 1
Defective Device 1
Mechanical Problem 1
Non Reproducible Results 1
Leak / Splash 1
Fumes or Vapors 1
Total Device Problems 8

Recalls
Manufacturer Recall Class Date Posted
1 Innovision A/S II Sep-08-2016

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