510(k) K170967
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 8, 2017
- Date Received
- March 31, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, X-Ray, Extraoral With Timer
- Device Class
- Class II
- Regulation Number
- 872.1800
- Review Panel
- RA
- Submission Type