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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator, auditory, evoked response
Regulation Description Evoked response auditory stimulator.
Product CodeGWJ
Regulation Number 882.1900
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO-LOGIC SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 7
EXCEL TECH. LTD.
  SUBSTANTIALLY EQUIVALENT 1
GN OTOMETRICS A/S
  SUBSTANTIALLY EQUIVALENT 2
INTELLIGENT HEARING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 7
INTERACOUSTICS A/S
  SUBSTANTIALLY EQUIVALENT 2
MAICO DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
VIVOSONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2

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

Recalls
Manufacturer Recall Class Date Posted
1 Intelligent Hearing Systems Corp. II May-27-2010
2 Natus Medical Inc II Aug-03-2010

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