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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device standard polysomnograph with electroencephalograph
Regulation Description Electroencephalograph.
Definition Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.
Product CodeOLV
Regulation Number 882.1400
Device Class 2


Premarket Reviews
ManufacturerDecision
AIRSEP CORP.
  SUBSTANTIALLY EQUIVALENT 2
BIO-LOGIC SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 3
COMPUMEDICS
  SUBSTANTIALLY EQUIVALENT 1
EB NEURO, S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
EXCEL TECH. LTD.
  SUBSTANTIALLY EQUIVALENT 2
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 9
SENSORMEDICS
  SUBSTANTIALLY EQUIVALENT 3

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