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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
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
ADVANCED BRAIN MONITORING INC.
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED BRAIN MONITORING, INC.
  SUBSTANTIALLY EQUIVALENT 2
BYTEFLIES NV
  SUBSTANTIALLY EQUIVALENT 1
CERIBELL, INC.
  SUBSTANTIALLY EQUIVALENT 1
EPITEL, INC.
  SUBSTANTIALLY EQUIVALENT 2
HEADSAFE MFG PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
JORDAN NEUROSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEBA HEALTH, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEURALYNX INC
  SUBSTANTIALLY EQUIVALENT 1
NEUROSTEER INC.
  SUBSTANTIALLY EQUIVALENT 1
NEUROWAVE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

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

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 1 1
Device Markings/Labelling Problem 1 1
Failure of Device to Self-Test 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3

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