510(k) K223581
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 2023
- Date Received
- December 1, 2022
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Ablation, Microwave And Accessories
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type