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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device magnetoencephalograph
Definition Acquire, display, store, and archive biomagnetic signals produced by electrically active nerve tissue in the brain to provide information about the location of active nerve tissue responsible for certain brain functions relative to brain anatomy.
Product CodeOLY
Regulation Number 882.1400
Device Class 2


Premarket Reviews
ManufacturerDecision
COMPUMEDICS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
TRISTAN TECHNOLOGIES INC
  SUBSTANTIALLY EQUIVALENT 1
TRISTAN TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 1

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