QVC

Ventilator Waveform Analysis Software

Product code
QVC
Device name
Ventilator Waveform Analysis Software
Device class
Class 2
21 CFR
21 CFR 868.5896
Medical specialty
Anesthesiology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-06-18.

NumberDecision dateApplicantDevice nameSummary
DEN2500252026-06-18Autonomous Healthcare, Inc.Syncron-E
Official FDA classification page: QVC
Classification and pathway per current FDA publications. Data from openFDA (CC0).