510(k) K033316
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 14, 2004
- Date Received
- October 15, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Couch, Radiation Therapy, Powered
- Device Class
- Class II
- Regulation Number
- 892.5770
- Review Panel
- RA
- Submission Type