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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device reduced- montage standard electroencephalograph
Regulation Description Electroencephalograph.
Definition Acquire, display, store, and archive electroencephalographic signals from the brain using a user-specified and/or sponsor-specified locations with a reduced array (i.e. less than < 16) of electrodes
Product CodeOMC
Regulation Number 882.1400
Device Class 2


Premarket Reviews
ManufacturerDecision
EPITEL
  SUBSTANTIALLY EQUIVALENT 1
EPITEL, INC.
  SUBSTANTIALLY EQUIVALENT 2
FOREST DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 2
NAOX TECHNOLOGIES SAS
  SUBSTANTIALLY EQUIVALENT 1
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)
  SUBSTANTIALLY EQUIVALENT 1
NEBA HEALTH, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEUROSTEER, INC.
  SUBSTANTIALLY EQUIVALENT 1
QX WORLD, LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 2 2
2024 2 2
2025 2 2
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Markings/Labelling Problem 2 2
No Display/Image 1 1
Patient-Device Incompatibility 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Incorrect Measurement 1 1
Failure of Device to Self-Test 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
Hypersensitivity/Allergic reaction 1 1
Itching Sensation 1 1
Insufficient Information 1 1
Chest Pain 1 1
Swollen Lymph Nodes/Glands 1 1

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