510(k) K062265
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 26, 2006
- Date Received
- August 4, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Injector, Contrast Medium, Automatic
- Device Class
- Class II
- Regulation Number
- 870.1650
- Review Panel
- HO
- Submission Type