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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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
ERESEARCHTECHNOLOGY GMBH
  SUBSTANTIALLY EQUIVALENT 2
GUANGZHOU HOMESUN MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL GRAPHICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VIRTUS TECHNOLOGY APS
  SUBSTANTIALLY EQUIVALENT 1
VITALOGRAPH IRELAND, LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 2 2
2022 2 2
2023 1 1
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Battery Problem 5 5
Overheating of Device 2 2
Smoking 2 2
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10 10

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