510(k) K852638

HUMPHREY IMAGE ANALYZER MODEL 110 by Zeiss Humphrey System — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1985
Date Received
June 20, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Ophthalmic, Ac-Powered
Device Class
Class II
Regulation Number
886.1120
Review Panel
OP
Submission Type