510(k) K850813
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 1985
- Date Received
- February 28, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Barrier, Control Panel, X-Ray, Movable
- Device Class
- Class I
- Regulation Number
- 892.6500
- Review Panel
- RA
- Submission Type