510(k) K913121

OMNIFLEX OVERHEAD TUBECRANE CAT.#S-9108/#6713.400 by Continental X-Ray Corp. — Product Code KXJ

K913121 is an FDA 510(k) premarket notification submitted by Continental X-Ray Corp. for the device "OMNIFLEX OVERHEAD TUBECRANE CAT.#S-9108/#6713.400". The FDA issued a decision of Substantially Equivalent on August 16, 1991. The device falls under product code KXJ (Table, Radiologic), 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 16, 1991
Date Received
July 16, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Radiologic
Device Class
Class II
Regulation Number
892.1980
Review Panel
RA
Submission Type