510(k) K161131
K161131 is an FDA 510(k) premarket notification submitted by Fona S.R.L for the device "FONA Pan/Ceph". The FDA issued a decision of Substantially Equivalent on Nov 3, 2016. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Fona S.R.L has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 3, 2016
- Date Received
- Apr 21, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Extraoral Source, Digital
- Device Class
- Class II
- Regulation Number
- 872.1800
- Review Panel
- RA
- Submission Type
- 510(k)