510(k) K896099

DIGIGRAPH DIAGNOSTIC WORK/STATION by Dolphin Imaging Systems — Product Code EAG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1991
Date Received
October 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cephalometer
Device Class
Class II
Regulation Number
872.1830
Review Panel
RA
Submission Type