510(k) K090279
K090279 is an FDA 510(k) premarket notification submitted by Sedecal., Sa. for the device "SEDECAL, MILLENNIUM PLUS". The FDA issued a decision of Substantially Equivalent on March 11, 2009. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Sedecal., Sa. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 2009
- Date Received
- February 4, 2009
- Clearance Type
- Special
- 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