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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device conditioner, signal, physiological
Regulation Description Physiological signal conditioner.
Product CodeGWK
Regulation Number 882.1845
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO-LOGIC SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 2
ELMED
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 2
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 3

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