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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device nystagmograph
Regulation Description Nystagmograph.
Product CodeGWN
Regulation Number 882.1460
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO-LOGIC SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 2
GN OTOMETRICS A/S
  SUBSTANTIALLY EQUIVALENT 1
INTERACOUSTICS A/S
  SUBSTANTIALLY EQUIVALENT 1
NEURO KINETICS
  SUBSTANTIALLY EQUIVALENT 1

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