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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
Product CodeGWE
Regulation Number 882.1890
Device Class 2


Premarket Reviews
ManufacturerDecision
CRYPTYCH PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSYS LLC
  SUBSTANTIALLY EQUIVALENT 1
METROVISION
  SUBSTANTIALLY EQUIVALENT 2
MICROMED S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 2 2
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Sparking 4 4
Material Frayed 2 2
Electrical /Electronic Property Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
No Known Impact Or Consequence To Patient 2 2

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