DEN250025
- 510(k) number
- DEN250025
- Device name
- Syncron-E
- Applicant
- Autonomous Healthcare, Inc. CA · US
- Product code
- QVC — Ventilator Waveform Analysis Software
- Decision date
- 2026-06-18
- Date received
- 2025-06-23
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Anesthesiology
Official FDA record: DEN250025
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.