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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search Show TPLC since Back To Search Results
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
ERESEARCH TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL GRAPHICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NDD MEDIZITECHNIK AG
  SUBSTANTIALLY EQUIVALENT 1
SHAPE MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Calibration Problem 8
Device Operational Issue 3
Incorrect Software Programming Calculations 2
Failure to Calibrate 2
Incorrect, Inadequate or Imprecise Result or Readings 2
Break 1
Temperature Problem 1
Computer Software Problem 1
Low Test Results 1
Failure to Power Up 1
Application Program Problem 1
Patient Data Problem 1
Patient Device Interaction Problem 1
Application Program Problem: Dose Calculation Error 1
Connection Problem 1
Electrical Power Problem 1
Sparking 1
Gas Leak 1
Programming Issue 1
Total Device Problems 31

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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