510(k) K010187

KIMAX, MODEL 1024 by Medical Metrics, Inc. — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2001
Date Received
January 22, 2001
Clearance Type
Abbreviated
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