510(k) K884930

COMPAX MODEL 40, 400, 400T by General Electric Co. — Product Code IZZ

K884930 is an FDA 510(k) premarket notification submitted by General Electric Co. for the device "COMPAX MODEL 40, 400, 400T". The FDA issued a decision of Substantially Equivalent on December 22, 1988. The device falls under product code IZZ (Table, Radiographic, Non-Tilting, Powered), a Class II device regulated under 21 CFR 892.1980. General Electric Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1988
Date Received
November 25, 1988
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