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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device noninvasive positive airway pressure system, facility use
Regulation Description Continuous ventilator.
Definition To mechanically assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas through noninvasive continuous positive airway pressure.
Product CodeSGR
Regulation Number 868.5895
Device Class 2


Premarket Reviews
ManufacturerDecision
FISHER &PAYKEL HEALTHCARE , LTD.
  SUBSTANTIALLY EQUIVALENT 1
INNACCEL TECHNOLOGIES PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1

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