510(k) K953950

FLUORO CATHETER by Cmt Medical Technologies, Ltd. — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1995
Date Received
August 22, 1995
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