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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
Product CodeBTY
Regulation Number 868.1890
Device Class 2


Premarket Reviews
ManufacturerDecision
COSMED SRL
  SUBSTANTIALLY EQUIVALENT 1
ERESEARCHTECHNOLOGY GMBH
  SUBSTANTIALLY EQUIVALENT 3
GUANGZHOU HOMESUN MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL GRAPHICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
VIRTUS TECHNOLOGY APS
  SUBSTANTIALLY EQUIVALENT 1
VITALOGRAPH IRELAND LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 3 3
2020 3 3
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
Smoking 3 3
Overheating of Device 2 2
Fumes or Vapors 1 1
Mechanical Problem 1 1
Output Problem 1 1
Electrical Power Problem 1 1
Defective Device 1 1
Patient Device Interaction Problem 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10 10
No Patient Involvement 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Injury 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 NDDd Medical Technologies, Inc. II Dec-03-2019
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