510(k) K973125

MAMMOLOADER BY C.M.A. SRL by C.M.A. — Product Code IXW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 1997
Date Received
August 20, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Processor, Radiographic-Film, Automatic
Device Class
Class II
Regulation Number
892.1900
Review Panel
RA
Submission Type