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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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Device
nystagmograph
Product Code
GWN
Regulation Number
882.1460
Device Class
2
Premarket Reviews
Manufacturer
Decision
INTERACOUSTICS A/S
SUBSTANTIALLY EQUIVALENT
1
NEUROBIT TECHNOLOGIES CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
NEUROLIGN USA, LLC
SUBSTANTIALLY EQUIVALENT
1
VESTIBULAR FIRST
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
5
5
2021
1
1
2022
1
1
2023
3
3
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Overheating of Device
4
4
Adverse Event Without Identified Device or Use Problem
2
2
Output Problem
1
1
Break
1
1
False Positive Result
1
1
Fracture
1
1
Failure to Power Up
1
1
Defective Device
1
1
Communication or Transmission Problem
1
1
Detachment of Device or Device Component
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Not Applicable
4
4
No Clinical Signs, Symptoms or Conditions
4
4
Skin Inflammation/ Irritation
1
1
Head Injury
1
1
Hearing Impairment
1
1
Pain
1
1
Visual Impairment
1
1
No Known Impact Or Consequence To Patient
1
1
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