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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device full-montage standard electroencephalograph
Regulation Description Electroencephalograph.
Definition Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations
Product CodeGWQ
Regulation Number 882.1400
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 2
BIO-LOGIC SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 5
CLEVELAND CLINIC
  SUBSTANTIALLY EQUIVALENT 1
COMPUMEDICS
  SUBSTANTIALLY EQUIVALENT 1
DURDEN ENTERPRISES
  SUBSTANTIALLY EQUIVALENT 1
EXCEL TECH. LTD.
  SUBSTANTIALLY EQUIVALENT 15
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 17
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
XLTEK
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Incorrect measurement 7
Spark 4
Device inoperable 2
Fire 2
No Known Device Problem 2
Power source issue 2
No Information 2
Device handling issue 1
Shock, electrical 1
Overheating of device or device component 1
Device stops intermittently 1
Use of Device Issue 1
Unknown (for use when the device problem is not known) 1
Device sensing issue 1
Total Device Problems 28

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 3 3 0 1 0 1 1 0 1 1
Class III 1 1 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Bio-Logic Systems Corp II Nov-03-2007
2 Bio-Logic Systems Corp II Apr-20-2007
3 Cardinal Health NeuroCare Division II Sep-23-2008
4 Cardinal Health NeuroCare Division II Sep-21-2008
5 CareFusion II Apr-07-2010
6 Natus Neurology DBA Excel Tech., Ltd. (XLTEK) II Jan-04-2016
7 Natus Neurology Inc II Oct-13-2015
8 Nicolet Biomedical Div of Viasys Healthcare III Jan-03-2008
9 Nicolet Biomedical Div of Viasys Healthcare II Sep-20-2007
10 Nicolet Biomedical Div of Viasys Healthcare III Feb-15-2007
11 Respironics, Inc. II Apr-24-2008
12 Stellate Systems II Apr-22-2013
13 Stellate Systems II Jan-11-2012

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