510(k) K080738
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 13, 2008
- Date Received
- March 17, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, X-Ray, Intraoral
- Device Class
- Class II
- Regulation Number
- 872.1810
- Review Panel
- RA
- Submission Type