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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device intra-pulmonary percussive vibration (ipv) devices
Regulation Description Powered percussor.
Definition It is intended to mobilize mucus using vibration and/or pressure delivered through a mouthpiece into the airways.
Product CodeSDT
Regulation Number 868.5665
Device Class 2


Premarket Reviews
ManufacturerDecision
INOGEN, INC.
  SUBSTANTIALLY EQUIVALENT 1

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