510(k) K233486
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 13, 2024
- Date Received
- October 27, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Continuous, Facility Use
- Device Class
- Class II
- Regulation Number
- 868.5895
- Review Panel
- AN
- Submission Type