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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
CRYPTYCH PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
NATUS MEDICAL INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 2 2
2018 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Thermal Decomposition of Device 2 2
Electrical /Electronic Property Problem 2 2
Sparking 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 4 4

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