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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ventilator waveform analysis software
Definition Ventilator waveform analysis software is a prescription device that uses software algorithms to analyze mechanical ventilation waveform data to detect, display, and summarize patient-ventilator interactions. The device provides results to healthcare providers as an aid to monitoring or clinical assessment.
Product CodeQVC
Regulation Number 868.5896
Device Class 2


Premarket Reviews
ManufacturerDecision
AUTONOMOUS HEALTHCARE, INC.
  GRANTED 1

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