510(k) K092329
K092329 is an FDA 510(k) premarket notification submitted by Sopro for the device "SOPIX 2". The FDA issued a decision of Substantially Equivalent on July 20, 2010. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Sopro has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 20, 2010
- Date Received
- August 4, 2009
- 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