510(k) K182206
K182206 is an FDA 510(k) premarket notification submitted by Trident S.R.L for the device "RiX70 DC". The FDA issued a decision of Substantially Equivalent on Sep 13, 2018. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Trident S.R.L has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 13, 2018
- Date Received
- Aug 15, 2018
- 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
- 510(k)