510(k) K963333

OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340) by Karl Storz Imaging, Inc. — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1996
Date Received
August 23, 1996
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