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TPLC
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Device
calculator, predicted values, pulmonary function
Product Code
BTY
Regulation Number
868.1890
Device Class
2
Premarket Reviews
Manufacturer
Decision
COSMED SRL
SUBSTANTIALLY EQUIVALENT
1
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
2019
3
3
2020
3
3
2021
2
2
2022
2
2
2023
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Smoking
3
3
Overheating of Device
2
2
Mechanical Problem
1
1
Fumes or Vapors
1
1
Defective Device
1
1
Electrical Power Problem
1
1
Output Problem
1
1
Temperature Problem
1
1
Patient Device Interaction Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
5
5
No Patient Involvement
3
3
Insufficient Information
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
NDDd Medical Technologies, Inc.
II
Dec-03-2019
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