510(k) K840225

C-ARM CEILING CRANE FT-2 by Medicor USA , Ltd. — Product Code JAA

K840225 is an FDA 510(k) premarket notification submitted by Medicor USA , Ltd. for the device "C-ARM CEILING CRANE FT-2". The FDA issued a decision of Substantially Equivalent on March 22, 1984. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Medicor USA , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1984
Date Received
January 19, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type