510(k) K191719
K191719 is an FDA 510(k) premarket notification submitted by De Gotzen S.R.L. for the device "X-MIND Trium". The FDA issued a decision of Substantially Equivalent on Feb 20, 2020. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. De Gotzen S.R.L. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 20, 2020
- Date Received
- Jun 26, 2019
- 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)