FDA product code QVC: Ventilator Waveform Analysis Software
QVC is the FDA product code for ventilator waveform analysis software. It is a Class II device, regulated under 21 CFR 868.5896 and reviewed by the Anesthesiology panel. Devices under QVC reach the market by 510(k); FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Ventilator Waveform Analysis Software |
| Device class | Class II |
| Regulation | 21 CFR 868.5896 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
Recalls for QVC devices
openFDA lists no recalls for product code QVC.
Frequently asked questions
What is FDA product code QVC?
QVC is the FDA product code for ventilator waveform analysis software. It is a Class II device, regulated under 21 CFR 868.5896 and reviewed by the Anesthesiology panel.
What device class is QVC?
Class II, regulation 21 CFR 868.5896. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QVC
- Run a recall and safety report across every QVC manufacturer
- Watch product code QVC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.