510(k) K172810
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 7, 2018
- Date Received
- September 18, 2017
- Clearance Type
- Traditional
- 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