510(k) K940540

VELO ACE by Emix U.S.A., Inc. — Product Code IXW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1994
Date Received
February 7, 1994
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