510(k) K050019
K050019 is an FDA 510(k) premarket notification submitted by Kavo America for the device "IN EXAM INTRAORAL DENTAL X-RAY SYSTEM". The FDA issued a decision of Substantially Equivalent on Jan 31, 2005. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Kavo America has 19 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 31, 2005
- Date Received
- Jan 5, 2005
- 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)