510(k) K092103
K092103 is an FDA 510(k) premarket notification submitted by VATECH Co., Ltd. for the device "DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX)". The FDA issued a decision of Substantially Equivalent on Oct 9, 2009. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. VATECH Co., Ltd. has 39 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 9, 2009
- Date Received
- Jul 14, 2009
- 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)