510(k) K113066

CORVIS ST by Oculus Optikgerate GmbH — Product Code HKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2012
Date Received
October 17, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tonometer, Ac-Powered
Device Class
Class II
Regulation Number
886.1930
Review Panel
OP
Submission Type