510(k) K903160
K903160 is an FDA 510(k) premarket notification submitted by Continental X-Ray Corp. for the device "LIEBEL-FLARSHEIM SERIES 8000 BUCKY,W/NON SIZE SENS". The FDA issued a decision of Substantially Equivalent on August 8, 1990. The device falls under product code IXQ (Table, Radiographic, Stationary Top), 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
- August 8, 1990
- Date Received
- July 18, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Radiographic, Stationary Top
- Device Class
- Class II
- Regulation Number
- 892.1980
- Review Panel
- RA
- Submission Type