QVC
- 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.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| DEN250025 | 2026-06-18 | Autonomous Healthcare, Inc. | Syncron-E | — |
Official FDA classification page: QVC
Classification and pathway per current FDA publications. Data from openFDA (CC0).