510(k) K910648
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 22, 1991
- Date Received
- February 14, 1991
- 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