510(k) K132378
K132378 is an FDA 510(k) premarket notification submitted by De Gotzen S.R.L. for the device "X-MIND UNITY". The FDA issued a decision of Substantially Equivalent on May 30, 2014. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), 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
- May 30, 2014
- Date Received
- Jul 31, 2013
- Clearance Type
- Abbreviated
- 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)