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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device standard polysomnograph with electroencephalograph
Regulation Description Electroencephalograph.
Definition Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.
Product CodeOLV
Regulation Number 882.1400
Device Class 2


Premarket Reviews
ManufacturerDecision
CADWELL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CEREBRA MEDICAL , LTD.
  SUBSTANTIALLY EQUIVALENT 1
COMPUMEDICS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
NOX MEDICAL EHF
  SUBSTANTIALLY EQUIVALENT 1
SOMNOMEDICS GMBH
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 3 3
2022 3 3
2023 2 2
2024 2 2
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 3 3
Excessive Heating 2 2
Circuit Failure 1 1
Mechanical Problem 1 1
Unintended Electrical Shock 1 1
Electro-Static Discharge 1 1
Degraded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10 10
Nausea 1 1
Dizziness 1 1
Skin Inflammation/ Irritation 1 1
Vomiting 1 1
Unspecified Respiratory Problem 1 1
Headache 1 1

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