510(k) K913435
K913435 is an FDA 510(k) premarket notification submitted by Brotherston/Pxi for the device "PXI URCD". The FDA issued a decision of Substantially Equivalent on November 5, 1992. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Brotherston/Pxi has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 1992
- Date Received
- August 1, 1991
- 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