Syncron-E— 510(k) DEN250025
UnknownAutonomous Healthcare, Inc.
FDA 510(k) clearance DEN250025 for Syncron-E, Unknown on 2026-06-18. Applicant: Autonomous Healthcare, Inc.. Device class: 2.
Summary
Syncron-E from Autonomous Healthcare is filed under product code QVC, ventilator waveform analysis software. The record doesn't describe the software beyond its name and the code name.
Class II, 21 CFR 868.5896. Anesthesiology is both the classification panel and the review panel. The record lists the submission type as Direct.
Autonomous Healthcare filed from Santa Clara, California. The decision date came 360 calendar days after the received date (June 23, 2025 to June 18, 2026).
Clearance details
- Applicant
- Autonomous Healthcare, Inc.
- Product code
- Product code QVC
- Device class
- Class 2
- Regulation
- 21 CFR 868.5896
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Santa Clara, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.