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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device nystagmograph
Regulation Description Nystagmograph.
Product CodeGWN
Regulation Number 882.1460
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO-LOGIC SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 2
GN OTOMETRICS A/S
  SUBSTANTIALLY EQUIVALENT 1
INTERACOUSTICS A/S
  SUBSTANTIALLY EQUIVALENT 3
NEURO KINETICS
  SUBSTANTIALLY EQUIVALENT 1

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 0 0 0 0 0 0 0 2 2 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp. II Jul-17-2014
2 Neuro Kinetics, Inc. II Sep-03-2015
3 Neuro Kinetics, Inc. II Jun-12-2015
4 Neuro Kinetics, Inc. II Feb-10-2014

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