510(k) K051795
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 14, 2005
- Date Received
- July 5, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Unit, X-Ray, Extraoral With Timer
- Device Class
- Class II
- Regulation Number
- 872.1800
- Review Panel
- RA
- Submission Type