510(k) K111710

FULL AUTO TONOMETER MODEL TX-20 by Canon Inc. -Medical Equipment Group — Product Code HKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2011
Date Received
June 20, 2011
Clearance Type
Special
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