QVC

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Ventilator Waveform Analysis Software

Device class

Class II (moderate risk)

Regulation

21 CFR 868.5896

Medical specialty

Anesthesiology

FDA 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.

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