510(k) K243765
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 2025
- Date Received
- December 6, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilatory Electrical Impedance Tomograph
- Device Class
- Class II
- Regulation Number
- 868.1505
- Review Panel
- AN
- Submission Type
A ventilatory electrical impedance tomograph is a prescription non-invasive, non-radiological ventilatory device that provides an assessment of local impedance variation within a cross-section of a patients thorax.