510(k) K193207
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 2020
- Date Received
- November 20, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accelerator, Linear, Medical
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type