510(k) K933161

ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN by Dupont Medical Products — Product Code EAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 1993
Date Received
June 29, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screen, Intensifying, Radiographic
Device Class
Class I
Regulation Number
892.1960
Review Panel
RA
Submission Type