510(k) K110828
K110828 is an FDA 510(k) premarket notification submitted by Swissray Medical AG for the device "DDRELEMENT". The FDA issued a decision of Substantially Equivalent on Aug 23, 2011. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Swissray Medical AG has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 23, 2011
- Date Received
- Mar 24, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Stationary
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type