510(k) K893129
K893129 is an FDA 510(k) premarket notification submitted by Continental X-Ray Corp. for the device "CXC FFT-1 NON-TILT STAT RADIO XRAY TAB 4 WA FL TAB". The FDA issued a decision of Substantially Equivalent on June 1, 1989. The device falls under product code IZZ (Table, Radiographic, Non-Tilting, Powered), a Class II device regulated under 21 CFR 892.1980. Continental X-Ray Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 1, 1989
- Date Received
- April 25, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Radiographic, Non-Tilting, Powered
- Device Class
- Class II
- Regulation Number
- 892.1980
- Review Panel
- RA
- Submission Type