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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, positive pressure breathing, intermittent
Regulation Description Noncontinuous ventilator (IPPB).
Product CodeNHJ
Regulation Number 868.5905
Device Class 2


Premarket Reviews
ManufacturerDecision
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 2
PERCUSSIONAIRE CORP.
  SUBSTANTIALLY EQUIVALENT 2
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Air leak 1
Inadequate training 1
Total Device Problems 2

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