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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device respiratory effort belt for polysomnography
Regulation Description Electroencephalograph.
Definition To assess respiratory/breathing effort by measuring the movement of chest and abdominal walls. The belts function as accessories to sleep/polysomnography (PSG) and home sleep apnea test (HSAT) systems.
Product CodeSFK
Regulation Number 882.1400
Device Class 2


Premarket Reviews
ManufacturerDecision
NEUROTRONICS, LLC
  SUBSTANTIALLY EQUIVALENT 1

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