QVC — Ventilator Waveform Analysis Software Class II
FDA product code QVC covers "Ventilator Waveform Analysis Software", a Class II medical device regulated under 21 CFR 868.5896. Submissions are reviewed by the Anesthesiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QVC
- Device Class
- Class II
- Regulation Number
- 868.5896
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN250025 | Autonomous Healthcare | Syncron-E | Jun 18, 2026 |