510(k) K964137

RTA RETINAL THICKNESS ANALYZER by Talia Technology , Ltd. — Product Code HLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1997
Date Received
October 15, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Ac-Powered
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type