510(k) K042159

KODAK COLOR MEDICAL IMAGER 1000 by Eastman Kodak Company — Product Code LMC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2004
Date Received
August 10, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Multi Format, Radiological
Device Class
Class II
Regulation Number
892.2040
Review Panel
RA
Submission Type