510(k) K041290

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2004
Date Received
May 13, 2004
Clearance Type
Special
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