510(k) K222274
K222274 is an FDA 510(k) premarket notification submitted by Fona S.R.L for the device "FONA XDC". The FDA issued a decision of Substantially Equivalent on Aug 23, 2022. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), 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
- Aug 23, 2022
- Date Received
- Jul 29, 2022
- 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
- 510(k)