Ventilator Waveform Analysis Software
QVC is the FDA product code for Ventilator Waveform Analysis Software, a class II device type, regulated under 21 CFR 868.5896. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QVC
- Device name
- Ventilator Waveform Analysis Software
- 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.
- Regulation
- 21 CFR 868.5896
- Device class
- Class II
- Review panel
- Anesthesiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code QVC
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2026 | 1 |
Applicants with the most clearances
Product code QVC| Applicant | Clearances |
|---|---|
| Autonomous Healthcare, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code QVC.
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