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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator, photic, evoked response
Regulation Description Evoked response photic stimulator.
Product CodeGWE
Regulation Number 882.1890
Device Class 2


Premarket Reviews
ManufacturerDecision
AIRSEP CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIO-LOGIC SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 4
EXCEL TECH. LTD.
  SUBSTANTIALLY EQUIVALENT 2
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 2
VERISCI CORPORATION
  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 0 1 0
Class III 0 0 0 1 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Diopsys, Inc. III Apr-26-2010
2 Natus Medical Incorporated II Feb-09-2015

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