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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device amplitude-integrated electroencephalograph
Definition Measure and record electrical activity of the brain by acquisition of amplitude-integrated electroencephalograph (electroencephalograph signals that have been filtered and displayed in a specific manner).
Product CodeOMA
Regulation Number 882.1400
Device Class 2


Premarket Reviews
ManufacturerDecision
CADWELL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
EXCEL-TECH LTD. (XLTEK)
  SUBSTANTIALLY EQUIVALENT 1
MENNEN MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)
  SUBSTANTIALLY EQUIVALENT 1
NATUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 2
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Alarm System 1 1
Computer Software Problem 1 1
Display or Visual Feedback Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Seizures 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Moberg Research, Inc. II Apr-04-2023
2 Natus Neurology DBA Excel Tech., Ltd. (XLTEK) II Apr-01-2020
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