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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
NATUS MEDICAL INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Sparking 2
Electrical /Electronic Property Problem 2
Total Device Problems 4

Recalls
Manufacturer Recall Class Date Posted
1 Natus Medical Incorporated II Feb-09-2015

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