510(k) K893129

CXC FFT-1 NON-TILT STAT RADIO XRAY TAB 4 WA FL TAB by Continental X-Ray Corp. — Product Code IZZ

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