510(k) K233914
K233914 is an FDA 510(k) premarket notification submitted by Shenzhen Xpectvision Technology Co., Ltd. for the device "XVbeam2000". The FDA issued a decision of Substantially Equivalent on February 8, 2024. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Shenzhen Xpectvision Technology Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 2024
- Date Received
- December 12, 2023
- 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