510(k) DEN250025
DEN250025 is an FDA 510(k) premarket notification submitted by Autonomous Healthcare, Inc. for the device "Syncron-E". The FDA issued a decision of De Novo Granted on Jun 18, 2026. The device falls under product code QVC (Ventilator Waveform Analysis Software), a Class II device regulated under 21 CFR 868.5896.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Jun 18, 2026
- Date Received
- Jun 23, 2025
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator Waveform Analysis Software
- Device Class
- Class II
- Regulation Number
- 868.5896
- Review Panel
- AN
- Submission Type
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.