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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device source localization software for electroencephalograph or magnetoencephalograph
Regulation Description Electroencephalograph.
Definition Correlation of electrical activity of the brain using various neuroimaging modalities for source-localization
Product CodeOLX
Regulation Number 882.1400
Device Class 2


Premarket Reviews
ManufacturerDecision
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device maintenance issue 1
Total Device Problems 1

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