Syncron-E
FDA 510(k) clearance DEN250025 · decided 2026-06-18
Clearance details
- K-number
- DEN250025
- Device name
- Syncron-E
- Applicant
- Autonomous Healthcare, Inc.
- Decision
- Unknown
- Date received
- 2025-06-23
- Decision date
- 2026-06-18
- Days to decision
- 360 days
- Clearance type
- Direct
- Product code
- QVC
- Device class
- 2
- Regulation number
- 868.5896
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.