510(k) K060780

TONOMETER DIATON by Ryazan State Instruments — Product Code HKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2006
Date Received
March 22, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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