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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device non-normalizing quantitative electroencephalograph software
Definition Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.
Product CodeOLT
Regulation Number 882.1400
Device Class 2


Premarket Reviews
ManufacturerDecision
CADWELL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE FINLAND OY
  SUBSTANTIALLY EQUIVALENT 1
MOBERG RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
PASCALL SYSTEMS INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 2 2
2018 7 7
2019 2 2
2020 1 1
2021 6 6
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Temperature Problem 4 4
Display or Visual Feedback Problem 3 3
Overheating of Device 3 3
Smoking 3 3
Application Program Problem 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Output Problem 2 2
Power Problem 2 2
Appropriate Term/Code Not Available 2 2
Structural Problem 2 2
Detachment of Device or Device Component 1 1
Device Operates Differently Than Expected 1 1
Device Stops Intermittently 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 8 8
No Clinical Signs, Symptoms or Conditions 8 8
No Known Impact Or Consequence To Patient 3 3
Unspecified Tissue Injury 2 2
Death 2 2
Patient Problem/Medical Problem 1 1

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